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Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) (POINT X)

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ClinicalTrials.gov Identifier: NCT01229436
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dupuytren's Contracture
Intervention Drug: Xiapex
Enrollment 254
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Xiapex
Hide Arm/Group Description A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Period Title: Overall Study
Started 254
Completed 249
Not Completed 5
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             3
Arm/Group Title Xiapex
Hide Arm/Group Description A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Baseline Participants 254
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 254 participants
60.2  (7.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants
Female
31
  12.2%
Male
223
  87.8%
1.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Baseline for First Injection
Hide Description TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Baseline for first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set(FAS):participants who received at least (>=)1 injection of Xiapex,had >=1 post-injection efficacy assessment(goniometric/participant-reported). 'N’(number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
259
Median (Full Range)
Unit of Measure: degrees
55.0
(2 to 180)
2.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Baseline for Second Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Baseline for second injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. ‘N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
65
Median (Full Range)
Unit of Measure: degrees
45.0
(15 to 145)
3.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Baseline for Third Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Baseline for third injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
21
Median (Full Range)
Unit of Measure: degrees
40.0
(0 to 80)
4.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Baseline for fourth injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
1
Median (Full Range)
Unit of Measure: degrees
20.0
(20 to 20)
5.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 1 After First Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 1 after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
256
Median (Full Range)
Unit of Measure: degrees
20.0
(0 to 165)
6.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 7 After First Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 7 after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
256
Median (Full Range)
Unit of Measure: degrees
10.0
(0 to 110)
7.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 30 After First Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 30 after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
257
Median (Full Range)
Unit of Measure: degrees
10.0
(0 to 110)
8.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 1 After Second Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 1 after second injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
64
Median (Full Range)
Unit of Measure: degrees
29.0
(0 to 145)
9.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 7 After Second Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 7 after second injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
65
Median (Full Range)
Unit of Measure: degrees
20.0
(0 to 155)
10.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 30 After Second Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 30 after second injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
64
Median (Full Range)
Unit of Measure: degrees
20.0
(0 to 145)
11.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 1 After Third Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 1 after third injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
19
Median (Full Range)
Unit of Measure: degrees
15.0
(0 to 70)
12.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 7 After Third Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 7 after third injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
21
Median (Full Range)
Unit of Measure: degrees
22.0
(0 to 80)
13.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 30 After Third Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 30 after third injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
21
Median (Full Range)
Unit of Measure: degrees
30.0
(0 to 80)
14.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 1 after fourth injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
1
Median (Full Range)
Unit of Measure: degrees
0.0
(0 to 0)
15.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 7 after fourth injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
1
Median (Full Range)
Unit of Measure: degrees
0.0
(0 to 0)
16.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 30 after fourth injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
1
Median (Full Range)
Unit of Measure: degrees
10.0
(10 to 10)
17.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 90 After Last Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 90 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
244
Median (Full Range)
Unit of Measure: degrees
10.0
(0 to 120)
18.Primary Outcome
Title Total Passive Extension Deficit (TPED) at Day 180 After Last Injection
Hide Description TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Day 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
250
Median (Full Range)
Unit of Measure: degrees
14.5
(0 to 195)
19.Secondary Outcome
Title Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
Hide Description PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Time Frame Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
309
Median (Full Range)
Unit of Measure: degrees
Baseline for first injection: MP Joint (n=211)
40.0
(0 to 90)
Day 1 after first injection: MP Joint (n=207)
8.0
(0 to 80)
Day 7 after first injection: MP Joint (n=209)
0.0
(0 to 82)
Day 30 after first injection: MP Joint (n=209)
0.0
(0 to 70)
Baseline for second injection: MP Joint (n=33)
25.0
(0 to 74)
Day 1 after second injection: MP Joint (n=33)
5.0
(0 to 45)
Day 7 after second injection: MP Joint (n=33)
5.0
(0 to 50)
Day 30 after second injection: MP Joint (n=32)
8.5
(0 to 30)
Baseline for third injection: MP Joint (n=9)
20.0
(0 to 50)
Day 1 after third injection: MP Joint (n=9)
0.0
(0 to 50)
Day 7 after third injection: MP Joint (n=9)
10.0
(0 to 40)
Day 30 after third injection: MP Joint (n=9)
20.0
(0 to 40)
Baseline for follow-up: MP Joint (n=201)
40.0
(0 to 90)
Follow-up Day 90: MP Joint (n=201)
0.0
(0 to 70)
Follow-up Day 180: MP Joint (n=207)
0.0
(0 to 85)
Baseline for first injection: PIP Joint (n=98)
45.0
(15 to 94)
Day 1 after first injection: PIP Joint (n=98)
20.0
(0 to 80)
Day 7 after first injection: PIP Joint (n=97)
14.0
(0 to 90)
Day 30 after first injection: PIP Joint (n=98)
18.5
(0 to 90)
Baseline for second injection: PIP Joint (n=18)
40.0
(5 to 90)
Day 1 after second injection: PIP Joint (n=15)
30.0
(0 to 90)
Day 7 after second injection: PIP Joint (n=18)
30.0
(0 to 90)
Day 30 after second injection: PIP Joint (n=18)
27.0
(0 to 95)
Baseline for third injection: PIP Joint (n=6)
37.5
(20 to 80)
Day 1 after third injection: PIP Joint (n=6)
12.5
(0 to 70)
Day 7 after third injection: PIP Joint (n=6)
17.5
(0 to 80)
Day 30 after third injection: PIP Joint (n=6)
20.0
(5 to 80)
Baseline for follow-up: PIP Joint (n=93)
45.0
(15 to 94)
Follow-up Day 90: PIP Joint (n=93)
20.0
(0 to 80)
Follow-up Day 180: PIP Joint (n=93)
25.0
(0 to 80)
20.Secondary Outcome
Title Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection
Hide Description TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time Frame Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Fingers/Joints
257
Median (Full Range)
Unit of Measure: degrees
Change at Day 1 after first injection (n=256)
-31.0
(-145 to 35)
Change at Day 7 after first injection (n=256)
-40.0
(-160 to 15)
Change at Day 30 after first injection (n=257)
-40.0
(-155 to 7)
Change at Day 1 after second injection (n=64)
-20.0
(-85 to 33)
Change at Day 7 after second injection (n=65)
-20.0
(-85 to 31)
Change at Day 30 after second injection (n=64)
-20.0
(-89 to 31)
Change at Day 1 after third injection (n=19)
-15.0
(-45 to 3)
Change at Day 7 after third injection (n=21)
-10.0
(-45 to 20)
Change at Day 30 after third injection (n=21)
-10.0
(-20 to 20)
Change at Day 1 after fourth injection (n=1)
-20.0
(-20 to -20)
Change at Day 7 after fourth injection (n=1)
-20.0
(-20 to -20)
Change at Day 30 after fourth injection (n=1)
-10.0
(-10 to -10)
Change at Follow-up Day 90 (n=244)
-40.0
(-155 to 25)
Change at Follow-up Day 180 (n=250)
-35.0
(-165 to 50)
21.Secondary Outcome
Title Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection
Hide Description PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Time Frame Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
307
Median (Full Range)
Unit of Measure: degrees
Change at Day 1 after first injection: MP(n=207)
-30.0
(-90 to 25)
Change at Day 7 after first injection: MP(n=209)
-30.0
(-80 to 12)
Change at Day 30 after first injection: MP(n=209)
-35.0
(-80 to 10)
Change at Day 1 after second injection: MP(n=33)
-20.0
(-60 to 10)
Change at Day 7 after second injection: MP(n=33)
-20.0
(-58 to 20)
Change at Day 30 after second injection: MP(n=32)
-20.0
(-68 to 10)
Change at Day 1 after third injection: MP(n=9)
-10.0
(-30 to 0)
Change at Day 7 after third injection: MP(n=9)
-10.0
(-30 to 10)
Change at Day 30 after third injection: MP(n=9)
-10.0
(-10 to 10)
Change at Follow-up Day 90: MP(n=201)
-35.0
(-88 to 10)
Change at Follow-up Day 180: MP(n=207)
-35.0
(-82 to 20)
Change at Day 1 after first injection: PIP(n=98)
-25.0
(-90 to 33)
Change at Day 7 after first injection: PIP(n=97)
-30.0
(-90 to 31)
Change at Day 30 after first injection: PIP(n=98)
-30.0
(-94 to 31)
Change at Day 1 after second injection: PIP(n=15)
-10.0
(-42 to 6)
Change at Day 7 after second injection: PIP(n=18)
-12.5
(-45 to 6)
Change at Day 30 after second injection: PIP(n=18)
-14.5
(-40 to 10)
Change at Day 1 after third injection: PIP(n=6)
-20.0
(-30 to 0)
Change at Day 7 after third injection: PIP(n=6)
-16.5
(-35 to 0)
Change at Day 30 after third injection: PIP(n=6)
-15.0
(-20 to 0)
Change at Follow-up Day 90: PIP(n=93)
-20.0
(-90 to 25)
Change at Follow-up Day 180: PIP(n=93)
-20.0
(-94 to 25)
22.Secondary Outcome
Title Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
Hide Description Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Time Frame Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
307
Median (Full Range)
Unit of Measure: degrees
Baseline for first injection: MP Joint (n=208)
45.0
(0 to 90)
Day 1 after first injection: MP Joint (n=207)
65.0
(10 to 90)
Day 7 after first injection: MP Joint (n=209)
80.0
(-42 to 105)
Day 30 after first injection: MP Joint (n=209)
86.0
(20 to 105)
Baseline for second injection: MP Joint (n=33)
60.0
(10 to 90)
Day 1 after second injection: MP Joint (n=33)
76.0
(20 to 90)
Day 7 after second injection: MP Joint (n=32)
80.0
(6 to 95)
Day 30 after second injection: MP Joint (n=32)
80.0
(28 to 95)
Baseline for third injection: MP Joint (n=9)
70.0
(40 to 90)
Day 1 after third injection: MP Joint (n=9)
90.0
(40 to 90)
Day 7 after third injection: MP Joint (n=9)
80.0
(45 to 90)
Day 30 after third injection: MP Joint (n=9)
70.0
(50 to 90)
Baseline for follow-up: MP Joint (n=198)
45.0
(0 to 90)
Follow-up Day 90: MP Joint (n=201)
90.0
(20 to 110)
Follow-up Day 180: MP Joint (n=207)
90.0
(10 to 110)
Baseline for first injection: PIP Joint (n=98)
50.0
(0 to 85)
Day 1 after first injection: PIP Joint (n=98)
63.0
(10 to 100)
Day 7 after first injection: PIP Joint (n=97)
75.0
(10 to 110)
Day 30 after first injection: PIP Joint (n=98)
75.5
(10 to 105)
Baseline for second injection: PIP Joint (n=18)
50.0
(10 to 85)
Day 1 after second injection: PIP Joint (n=15)
50.0
(10 to 90)
Day 7 after second injection: PIP Joint (n=18)
67.0
(20 to 90)
Day 30 after second injection: PIP Joint (n=18)
65.0
(10 to 90)
Baseline for third injection: PIP Joint (n=6)
57.5
(10 to 70)
Day 1 after third injection: PIP Joint (n=6)
80.0
(20 to 90)
Day 7 after third injection: PIP Joint (n=6)
80.0
(10 to 90)
Day 30 after third injection: PIP Joint (n=6)
72.5
(10 to 85)
Baseline for follow-up: PIP Joint (n=93)
50.0
(0 to 85)
Follow-up Day 90: PIP Joint (n=93)
72.0
(10 to 105)
Follow-up Day 180: PIP Joint (n=93)
70.0
(10 to 105)
23.Secondary Outcome
Title Participant Global Assessment of Treatment Satisfaction and Disease Severity
Hide Description Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.
Time Frame Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Measure Type: Number
Unit of Measure: participants
Baseline for cycle 1, severity: normal (n=254) 2
Baseline for cycle 1, severity: mild (n=254) 40
Baseline for cycle 1, severity: moderate (n=254) 128
Baseline for cycle 1, severity: severe (n=254) 84
C1D30, severity: normal (n=253) 63
C1D30, severity: mild (n=253) 114
C1D30, severity: moderate (n=253) 55
C1D30, severity: severe (n=253) 21
C1D30, TS: very satisfied (n=253) 153
C1D30, TS: satisfied (n=253) 73
C1D30, TS: neither satisfied/dissatisfied (n=253) 16
C1D30, TS: dissatisfied (n=253) 6
C1D30, TS: very dissatisfied (n=253) 5
C1D30, improvement: 0% (n=252) 10
C1D30, improvement: 10% (n=252) 11
C1D30, improvement: 20% (n=252) 6
C1D30, improvement: 30% (n=252) 8
C1D30, improvement: 40% (n=252) 6
C1D30, improvement: 50% (n=252) 20
C1D30, improvement: 60% (n=252) 15
C1D30, improvement: 70% (n=252) 19
C1D30, improvement: 80% (n=252) 52
C1D30, improvement: 90% (n=252) 58
C1D30, improvement: 100% (n=252) 47
Baseline for cycle 2, severity: mild (n=112) 22
Baseline for cycle 2, severity: moderate (n=112) 62
Baseline for cycle 2, severity: severe (n=112) 28
C2D30, severity: normal (n=109) 27
C2D30, severity: mild (n=109) 47
C2D30, severity: moderate (n=109) 24
C2D30, severity: severe (n=109) 11
C2D30, TS: very satisfied (n=109) 64
C2D30, TS: satisfied (n=109) 37
C2D30, TS: neither satisfied/dissatisfied (n=109) 6
C2D30, TS: dissatisfied (n=109) 1
C2D30, TS: very dissatisfied (n=109) 1
C2D30, improvement: 0% (n=109) 4
C2D30, improvement: 10% (n=109) 1
C2D30, improvement: 20% (n=109) 2
C2D30, improvement: 30% (n=109) 7
C2D30, improvement: 40% (n=109) 4
C2D30, improvement: 50% (n=109) 10
C2D30, improvement: 60% (n=109) 9
C2D30, improvement: 70% (n=109) 8
C2D30, improvement: 80% (n=109) 13
C2D30, improvement: 90% (n=109) 33
C2D30, improvement: 100% (n=109) 18
Baseline for cycle 3, severity: normal (n=54) 1
Baseline for cycle 3, severity: mild (n=54) 14
Baseline for cycle 3, severity: moderate (n=54) 25
Baseline for cycle 3, severity: severe (n=54) 14
C3D30, severity: normal (n=54) 8
C3D30, severity: mild (n=54) 26
C3D30, severity: moderate (n=54) 16
C3D30, severity: severe (n=54) 4
C3D30, TS: very satisfied (n=54) 29
C3D30, TS: satisfied (n=54) 18
C3D30, TS: neither satisfied/dissatisfied (n=54) 4
C3D30, TS: dissatisfied (n=54) 3
C3D30, improvement: 0% (n=54) 2
C3D30, improvement: 10% (n=54) 1
C3D30, improvement: 20% (n=54) 1
C3D30, improvement: 30% (n=54) 3
C3D30, improvement: 40% (n=54) 2
C3D30, improvement: 60% (n=54) 7
C3D30, improvement: 70% (n=54) 11
C3D30, improvement: 80% (n=54) 8
C3D30, improvement: 90% (n=54) 16
C3D30, improvement: 100% (n=54) 3
Baseline for cycle 4, severity: mild (n=24) 11
Baseline for cycle 4, severity: moderate (n=24) 9
Baseline for cycle 4, severity: severe (n=24) 4
C4D30, severity: normal (n=24) 2
C4D30, severity: mild (n=24) 13
C4D30, severity: moderate (n=24) 8
C4D30, severity: severe (n=24) 1
C4D30, TS: very satisfied (n=24) 13
C4D30, TS: satisfied (n=24) 9
C4D30, TS: dissatisfied (n=24) 2
C4D30, improvement: 10% (n=24) 2
C4D30, improvement: 20% (n=24) 1
C4D30, improvement: 40% (n=24) 2
C4D30, improvement: 50% (n=24) 3
C4D30, improvement: 60% (n=24) 3
C4D30, improvement: 70% (n=24) 3
C4D30, improvement: 80% (n=24) 5
C4D30, improvement: 90% (n=24) 2
C4D30, improvement: 100% (n=24) 3
Baseline for cycle 5, severity: mild (n=12) 7
Baseline for cycle 5, severity: moderate (n=12) 4
Baseline for cycle 5, severity: severe (n=12) 1
C5D30, severity: normal (n= 12) 1
C5D30, severity: mild (n= 12) 6
C5D30, severity: moderate (n= 12) 4
C5D30, severity: severe (n= 12) 1
C5D30, TS: very satisfied (n= 12) 8
C5D30, TS: satisfied (n= 12) 3
C5D30, TS: neither satisfied/dissatisfied (n= 12) 1
C5D30, improvement: 10% (n= 12) 1
C5D30, improvement: 70% (n= 12) 2
C5D30, improvement: 80% (n= 12) 4
C5D30, improvement: 90% (n= 12) 5
FU Day 90, severity: normal (n=246) 92
FU Day 90, severity: mild (n=246) 102
FU Day 90, severity: moderate (n=246) 43
FU Day 90, severity: severe (n=246) 9
FU Day 90, TS: very satisfied (n=247) 163
FU Day 90, TS: satisfied (n=247) 57
FU Day 90,TS:neither satisfied/dissatisfied(n=247) 10
FU Day 90, TS: satisfaction: dissatisfied (n=247) 13
FU Day 90, TS:very dissatisfied (n=247) 4
FU Day 90, improvement: 0% (n=247) 7
FU Day 90, improvement: 10% (n=247) 4
FU Day 90, improvement: 20% (n=247) 6
FU Day 90, improvement: 30% (n=247) 3
FU Day 90, improvement: 40% (n=247) 6
FU Day 90, improvement: 50% (n=247) 13
FU Day 90, improvement: 60% (n=247) 5
FU Day 90, improvement: 70% (n=247) 20
FU Day 90, improvement: 80% (n=247) 42
FU Day 90, improvement: 90% (n=247) 78
FU Day 90, improvement: 100% (n=247) 63
FU Day 180, severity: normal (n=248) 78
FU Day 180, severity: mild (n=248) 96
FU Day 180, severity: moderate (n=248) 54
FU Day 180, severity: severe (n=248) 20
FU Day 180, TS: very satisfied (n=249) 152
FU Day 180, TS: satisfied (n=249) 64
FU Day180,TS:neither satisfied/dissatisfied(n=249) 13
FU Day 180,TS: dissatisfied (n=249) 15
FU Day 180,TS: very dissatisfied (n=249) 5
FU Day 180, improvement: 0% (n=249) 17
FU Day 180, improvement: 10% (n=249) 5
FU Day 180, improvement: 20% (n=249) 2
FU Day 180, improvement: 30% (n=249) 4
FU Day 180, improvement: 40% (n=249) 4
FU Day 180, improvement: 50% (n=249) 15
FU Day 180, improvement: 60% (n=249) 6
FU Day 180, improvement: 70% (n=249) 21
FU Day 180, improvement: 80% (n=249) 43
FU Day 180, improvement: 90% (n=249) 74
FU Day 180, improvement: 100% (n=249) 58
24.Secondary Outcome
Title Physician Global Assessment of Treatment Satisfaction and Disease Severity
Hide Description Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician’s rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.
Time Frame Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Measure Type: Number
Unit of Measure: participants
Baseline for cycle 1, severity: mild (n=254) 51
Baseline for cycle 1, severity: moderate (n=254) 138
Baseline for cycle 1, severity: severe (n=254) 65
C1D30, severity: normal (n=250) 60
C1D30, severity: mild (n=250) 106
C1D30, severity: moderate (n=250) 62
C1D30, severity: severe (n=250) 22
C1D30, TS: very satisfied (n=250) 134
C1D30, TS: satisfied (n=250) 90
C1D30, TS: neither satisfied/dissatisfied (n=250) 14
C1D30, TS: dissatisfied (n=250) 7
C1D30, TS: very dissatisfied (n=250) 5
C1D30, improvement: very much improved (n=250) 121
C1D30, improvement: much improved (n=250) 88
C1D30, improvement: minimally improved (n=250) 26
C1D30, improvement: no change (n=250) 14
C1D30, improvement: minimally worse (n=250) 1
Baseline for cycle 2, severity: mild (n=110) 33
Baseline for cycle 2, severity: moderate (n=110) 53
Baseline for cycle 2, severity: severe (n=110) 24
C2D30, severity: normal (n=108) 20
C2D30, severity: mild (n=108) 51
C2D30, severity: moderate (n=108) 28
C2D30, severity: severe (n=108) 9
C2D30, TS: very satisfied (n=108) 63
C2D30, TS: satisfied (n=108) 36
C2D30, TS: neither satisfied/dissatisfied (n=108) 5
C2D30, TS: dissatisfied (n=108) 3
C2D30, TS: very dissatisfied (n=108) 1
C2D30,improvement:very much improved (n=108) 41
C2D30, improvement:much improved (n=108) 55
C2D30, improvement:minimally improved (n=108) 8
C2D30, improvement:no change (n=108) 4
Baseline for cycle 3, severity: mild (n=53) 16
Baseline for cycle 3, severity: moderate (n=53) 25
Baseline for cycle 3, severity: severe (n=53) 12
C3D30, severity: normal (n=53) 9
C3D30, severity: mild (n=53) 24
C3D30, severity: moderate (n=53) 13
C3D30, severity: severe (n=53) 7
C3D30, TS: very satisfied (n=53) 26
C3D30, TS: satisfied (n=53) 22
C3D30, TS: neither satisfied/dissatisfied (n=53) 4
C3D30, TS: dissatisfied (n=53) 1
C3D30, improvement: very much improved (n=53) 22
C3D30, improvement: much improved (n=53) 24
C3D30, improvement: minimally improved (n=53) 5
C3D30, improvement: no change (n=53) 2
Baseline for cycle 4, severity: mild (n=24) 10
Baseline for cycle 4, severity: moderate (n=24) 9
Baseline for cycle 4, severity: severe (n=24) 5
C4D30, severity: normal (n=24) 2
C4D30, severity: mild (n=24) 11
C4D30, severity: moderate (n=24) 8
C4D30, severity: severe (n=24) 3
C4D30, TS: very satisfied (n=24) 4
C4D30, TS: satisfied (n=24) 15
C4D30, TS: neither satisfied/dissatisfied (n=24) 1
C4D30, TS: dissatisfied (n=24) 1
C4D30, improvement: very much improved (n=24) 6
C4D30, improvement: much improved (n=24) 14
C4D30, improvement: minimally improved (n=24) 3
C4D30, improvement: no change (n=24) 1
Baseline for cycle 5, severity: mild (n=12) 5
Baseline for cycle 5, severity: moderate (n=12) 5
Baseline for cycle 5, severity: severe (n=12) 2
C5D30, severity: mild (n= 12) 7
C5D30, severity: moderate (n= 12) 3
C5D30, severity: severe (n= 12) 2
C5D30, TS: very satisfied (n= 12) 7
C5D30, TS: satisfied (n= 12) 3
C5D30, TS: neither satisfied/dissatisfied (n= 12) 2
C5D30, improvement: very much improved (n=12) 5
C5D30, improvement: much improved (n=12) 5
C5D30, improvement: minimally improved (n=12) 1
C5D30, improvement: no change (n=12) 1
FU Day 90, severity: normal (n=247) 70
FU Day 90, severity: mild (n=247) 117
FU Day 90, severity: moderate (n=247) 51
FU Day 90, severity: severe (n=247) 9
FU Day 90, TS: very satisfied (n=247) 145
FU Day 90, TS: satisfied (n=247) 75
FU Day 90,TS:neither satisfied/dissatisfied(n=247) 15
FU Day 90, TS: dissatisfied (n=247) 10
FU Day 90, TS: very dissatisfied (n=247) 2
FU Day 90, improvement: very much improved (n=247) 123
FU Day 90, improvement: much improved (n=247) 95
FU Day 90, improvement: minimally improved (n=247) 17
FU Day 90, improvement: no change (n=247) 11
FU Day 90, improvement: much worse (n=247) 1
FU Day 180, severity: normal (n=249) 67
FU Day 180, severity: mild (n=249) 114
FU Day 180, severity: moderate (n=249) 47
FU Day 180, severity: severe (n=249) 21
FU Day 180, TS: very satisfied (n=249) 117
FU Day 180, TS: satisfied (n=249) 97
FU Day180,TS:neither satisfied/dissatisfied(n=249) 15
FU Day 180, TS: dissatisfied (n=249) 12
FU Day 180, TS: very dissatisfied(n=249) 8
FU Day 180, improvement:very much improved(n=249) 94
FU Day 180, improvement: much improved (n=249) 114
FU Day 180, improvement:minimally improved(n=249) 18
FU Day 180, improvement:no change (n=249) 13
FU Day 180, improvement: minimally worse (n=249) 5
FU Day 180, improvement: much worse (n=249) 4
FU Day 180, improvement: very much worse (n=249) 1
25.Secondary Outcome
Title Number of Participants With Type of Concomitant Pain Medication Used
Hide Description Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.
Time Frame Screening up to Day 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants who received at least 1 injection of Xiapex.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Measure Type: Number
Unit of Measure: participants
Acetylsalicylic acid 5
Other analgesics 2
Aporex 1
Codis 1
Dihydrocodeine 1
Fentanyl 3
Galenic/Paracetamol/Codeine 2
Hot coldrex 1
Metamizole 4
Morphine 3
Oxycodone 1
Panadeine CO 11
Paracetamol 96
Paramol-118 1
Pregabalin 2
Solpadeine 1
Tramadol 7
Ultracet 2
26.Secondary Outcome
Title Number of Days of Concomitant Pain Medication Usage
Hide Description Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.
Time Frame Screening up to Day 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 136
Median (Full Range)
Unit of Measure: days
2.0
(1 to 340)
27.Secondary Outcome
Title Number of Days Assessed on Dupuytren’s Treatment Assessment Daily Diary Questionnaire
Hide Description Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).
Time Frame C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 230
Median (Full Range)
Unit of Measure: days
C1D1 to C1D30: Absent or on sick leave (n=230)
3.0
(1 to 16)
C1D1 to C1D30: Reduced work hours (n=230)
2.0
(1 to 16)
C1D1 to C1D30: Modified job duties (n=230)
2.0
(1 to 16)
C1D1 to C1D30: Not participated in hobbies (n=230)
5.0
(1 to 16)
C1D1 to C1D30: Fitted with splint (n=211)
12.0
(1 to 16)
C2D1 to C2D30: Absent or on sick leave (n=103)
3.0
(1 to 13)
C2D1 to C2D30: Reduced work hours (n=103)
2.0
(1 to 12)
C2D1 to C2D30: Modified job duties (n=103)
2.0
(1 to 12)
C2D1 to C2D30: Not participated in hobbies (n=103)
5.0
(1 to 15)
C2D1 to C2D30: Fitted with splint (n=96)
11.0
(1 to 16)
C3D1 to C3D30: Absent or on sick leave (n=51)
2.0
(1 to 15)
C3D1 to C3D30: Reduced work hours (n=51)
3.0
(1 to 14)
C3D1 to C3D30: Modified job duties (n=51)
3.0
(1 to 14)
C3D1 to C3D30: Not participated in hobbies (n=51)
3.0
(1 to 15)
C3D1 to C3D30: Fitted with splint (n=44)
10.0
(1 to 15)
C4D1 to C4D30: Absent or on sick leave (n=19)
2.5
(2 to 11)
C4D1 to C4D30: Reduced work hours (n=19)
2.0
(1 to 7)
C4D1 to C4D30: Modified job duties (n=19)
2.0
(1 to 7)
C4D1 to C4D30: Not participated in hobbies (n=19)
2.0
(1 to 11)
C4D1 to C4D30: Fitted with splint (n=15)
10.5
(4 to 16)
C5D1 to C5D30: Absent or on sick leave (n=6)
8.5
(5 to 12)
C5D1 to C5D30: Reduced work hours (n=6)
8.5
(1 to 16)
C5D1 to C5D30: Modified job duties (n=6)
10.5
(5 to 16)
C5D1 to C5D30: Not participated in hobbies (n=6)
13.0
(2 to 16)
C5D1 to C5D30: Fitted with splint (n=5)
11.0
(1 to 16)
28.Secondary Outcome
Title Time to Recovery
Hide Description Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.
Time Frame Up to Day 30 after first, second and third injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 230
Median (95% Confidence Interval)
Unit of Measure: days
First injection (n=230)
3.0
(3.0 to 4.0)
Second injection (n=103)
4.0
(2.0 to 5.0)
Third injection (n=51)
3.0
(2.0 to 4.0)
29.Secondary Outcome
Title Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score
Hide Description URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to >=5 items, then average score of answered questions was imputed response to missing questions.
Time Frame Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 126
Median (Full Range)
Unit of Measure: units on a scale
Baseline for cycle 1 (n=85)
13.0
(0 to 32)
C1D30 (n=89)
3.0
(0 to 29)
Baseline for cycle 2 (n=47)
7.0
(0 to 36)
C2D30 (n=51)
4.0
(0 to 36)
Baseline for cycle 3 (n=31)
8.0
(0 to 36)
C3D30 (n=31)
3.0
(0 to 32)
Baseline for cycle 4 (n=15)
6.0
(0 to 32)
C4D30 (n=15)
5.6
(0 to 32)
Baseline for cycle 5 (n=9)
9.0
(0 to 32)
C5D30 (n=9)
2.3
(0 to 28)
Baseline for Follow-up Day 90 (n=82)
13.0
(0 to 32)
Follow-up Day 90 (n=108)
1.0
(0 to 29)
Baseline for Follow-up Day 180 (n=83)
13.0
(0 to 32)
Follow-up Day 180 (n=126)
0.5
(0 to 38)
30.Secondary Outcome
Title Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Hide Description Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.
Time Frame Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Measure Type: Number
Unit of Measure: participants
Baseline cycle 1: Seen any doctor (n=254) 10
Baseline cycle 1: Received any therapy (n=254) 0
Baseline cycle 1:Treated in emergency room(n=254) 1
Baseline cycle 1: Outpatient surgery (n=254) 2
Baseline cycle 1: Hospitalization (n=254) 0
Baseline cycle 1: Diagnostic test (n=254) 2
Baseline cycle 1: In nursing home (n=254) 0
Baseline cycle 1: Required aids/devices (n=254) 1
C1D7: Seen any doctor (n=252) 21
C1D7: Received any therapy (n=252) 12
C1D7: Treated in emergency room (n=252) 4
C1D7: Outpatient surgery (n=252) 9
C1D7: Hospitalization (n=252) 1
C1D7: Diagnostic test (n=252) 2
C1D7: In nursing home (n=252) 0
C1D7: Required aids/devices (n=252) 1
C1D30: Seen any doctor (n=251) 14
C1D30: Received any therapy (n=251) 7
C1D30: Treated in emergency room (n=251) 2
C1D30: Outpatient surgery (n=251) 3
C1D30: Hospitalization (n=251) 2
C1D30: Diagnostic test (n=251) 4
C1D30: In nursing home (n=251) 0
C1D30: Required aids/devices (n=251) 1
Baseline cycle 2: Seen any doctor (n=111) 4
Baseline cycle 2: Received any therapy (n=111) 1
Baseline cycle 2:Treated in emergency room(n=111) 0
Baseline cycle 2: Outpatient surgery (n=111) 1
Baseline cycle 2: Hospitalization (n=111) 0
Baseline cycle 2: Diagnostic test (n=111) 2
Baseline cycle 2: In nursing home (n=111) 0
Baseline cycle 2: Required aids/devices (n=111) 0
C2D7: Seen any doctor (n=112) 4
C2D7: Received any therapy (n=112) 4
C2D7: Treated in emergency room (n=112) 0
C2D7: Outpatient surgery (n=112) 3
C2D7: Hospitalization (n=112) 0
C2D7: Diagnostic test (n=112) 0
C2D7: In nursing home (n=112) 0
C2D7: Required aids/devices (n=112) 1
C2D30: Seen any doctor (n=111) 5
C2D30: Received any therapy (n=111) 3
C2D30: Treated in emergency room (n=111) 0
C2D30: Outpatient surgery (n=111) 1
C2D30: Hospitalization (n=111) 1
C2D30: Diagnostic test (n=111) 2
C2D30: In nursing home (n=111) 0
C2D30: Required aids/devices (n=111) 1
Baseline cycle 3: Seen any doctor (n=51) 1
Baseline cycle 3: Received any therapy (n=51) 0
Baseline cycle 3:Treated in emergency room(n=51) 0
Baseline cycle 3: Outpatient surgery (n=51) 0
Baseline cycle 3: Hospitalization (n=51) 0
Baseline cycle 3: Diagnostic test (n=51) 2
Baseline cycle 3: In nursing home (n=51) 0
Baseline cycle 3: Required aids/devices (n=51) 0
C3D7: Seen any doctor (n=54) 1
C3D7: Received any therapy (n=54) 0
C3D7: Treated in emergency room (n=54) 0
C3D7: Outpatient surgery (n=54) 1
C3D7: Hospitalization (n=54) 0
C3D7: Diagnostic test (n=54) 0
C3D7: In nursing home (n=54) 0
C3D7: Required aids/devices (n=54) 0
C3D30: Seen any doctor (n=54) 2
C3D30: Received any therapy (n=54) 1
C3D30: Treated in emergency room (n=54) 0
C3D30: Outpatient surgery (n=54) 1
C3D30: Hospitalization (n=54) 0
C3D30: Diagnostic test (n=54) 0
C3D30: In nursing home (n=54) 0
C3D30: Required aids/devices (n=54) 1
Baseline cycle 4: Seen any doctor (n=23) 1
Baseline cycle 4: Received any therapy (n=23) 0
Baseline cycle 4:Treated in emergency room(n=23) 0
Baseline cycle 4: Outpatient surgery (n=23) 0
Baseline cycle 4: Hospitalization (n=23) 0
Baseline cycle 4: Diagnostic test (n=23) 0
Baseline cycle 4: In nursing home (n=23) 0
Baseline cycle 4: Required aids/devices (n=23) 1
C4D7: Seen any doctor (n=24) 0
C4D7: Received any therapy (n=24) 2
C4D7: Treated in emergency room (n=24) 0
C4D7: Outpatient surgery (n=24) 0
C4D7: Hospitalization (n=24) 0
C4D7: Diagnostic test (n=24) 0
C4D7: In nursing home (n=24) 0
C4D7: Required aids/devices (n=24) 0
C4D30: Seen any doctor (n=24) 1
C4D30: Received any therapy (n=24) 1
C4D30: Treated in emergency room (n=24) 0
C4D30: Outpatient surgery (n=24) 0
C4D30: Hospitalization (n=24) 0
C4D30: Diagnostic test (n=24) 0
C4D30: In nursing home (n=24) 0
C4D30: Required aids/devices (n=24) 0
Baseline cycle 5: Seen any doctor (n=12) 0
Baseline cycle 5: Received any therapy (n=12) 0
Baseline cycle 5:Treated in emergency room(n=12) 0
Baseline cycle 5: Outpatient surgery (n=12) 0
Baseline cycle 5: Hospitalization (n=12) 0
Baseline cycle 5: Diagnostic test (n=12) 0
Baseline cycle 5: In nursing home (n=12) 0
Baseline cycle 5: Required aids/devices (n=12) 0
C5D7: Seen any doctor (n=12) 0
C5D7: Received any therapy (n=12) 0
C5D7: Treated in emergency room (n=12) 0
C5D7: Outpatient surgery (n=12) 0
C5D7: Hospitalization (n=12) 0
C5D7: Diagnostic test (n=12) 0
C5D7: In nursing home (n=12) 0
C5D7: Required aids/devices (n=12) 0
C5D30: Seen any doctor (n=12) 0
C5D30: Received any therapy (n=12) 0
C5D30: Treated in emergency room (n=12) 0
C5D30: Outpatient surgery (n=12) 0
C5D30: Hospitalization (n=12) 0
C5D30: Diagnostic test (n=12) 0
C5D30: In nursing home (n=12) 0
C5D30: Required aids/devices (n=12) 0
Follow-up Day 90: Seen any doctor (n=247) 10
Follow-up Day 90: Received any therapy (n=247) 8
Follow-up Day 90:Treated in emergency room(n=247) 8
Follow-up Day 90: Outpatient surgery (n=247) 11
Follow-up Day 90: Hospitalization (n=247) 4
Follow-up Day 90: Diagnostic test (n=247) 4
Follow-up Day 90: In nursing home (n=247) 1
Follow-up Day 90:Required aids/devices(n=247) 1
Follow-up Day 180: Seen any doctor (n=249) 4
Follow-up Day 180: Received any therapy (n=249) 3
Follow-up Day 180:Treated in emergency room(n=249) 8
Follow-up Day 180: Outpatient surgery (n=249) 9
Follow-up Day 180: Hospitalization (n=248) 6
Follow-up Day 180: Diagnostic test (n=247) 1
Follow-up Day 180: In nursing home (n=248) 0
Follow-up Day 180: Required aids/devices (n=248) 3
31.Secondary Outcome
Title Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Hide Description Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.
Time Frame Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of events was not analyzed for participants who responded that they did not perform the event.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: events
Baseline cycle 1: Seen any doctor (n=10)
1.0
(1 to 2)
Baseline cycle 1: Treated in emergency room (n=1)
2.0
(2 to 2)
Baseline cycle 1: Outpatient surgery (n=2)
1.0
(1 to 1)
Baseline cycle 1: Diagnostic test (n=2)
1.0
(1 to 1)
C1D7: Seen any doctor (n=21)
1.0
(1 to 3)
C1D7: Received any therapy (n=12)
1.0
(1 to 6)
C1D7: Treated in emergency room (n=4)
1.0
(1 to 1)
C1D7: Outpatient surgery (n=8)
1.0
(1 to 2)
C1D7: Hospitalization (n=1)
1.0
(1 to 1)
C1D7: Diagnostic test (n=2)
1.0
(1 to 1)
C1D30: Seen any doctor (n=14)
2.0
(1 to 4)
C1D30: Received any therapy (n=7)
2.0
(1 to 3)
C1D30: Treated in emergency room (n=2)
1.0
(1 to 1)
C1D30: Outpatient surgery (n=3)
1.0
(1 to 1)
C1D30: Hospitalization (n=2)
1.0
(1 to 1)
C1D30: Diagnostic test (n=4)
1.0
(1 to 2)
Baseline cycle 2: Seen any doctor (n=4)
1.0
(1 to 2)
Baseline cycle 2: Received any therapy (n=1)
1.0
(1 to 1)
Baseline cycle 2: Outpatient surgery (n=1)
1.0
(1 to 1)
Baseline cycle 2: Diagnostic test (n=2)
1.0
(1 to 1)
C2D7: Seen any doctor (n=4)
1.0
(1 to 2)
C2D7: Received any therapy (n=3)
1.0
(1 to 2)
C2D7: Outpatient surgery (n=3)
1.0
(1 to 1)
C2D30: Seen any doctor (n=5)
1.0
(1 to 13)
C2D30: Received any therapy (n=3)
4.0
(3 to 10)
C2D30: Outpatient surgery (n=1)
1.0
(1 to 1)
C2D30: Hospitalization (n=1)
1.0
(1 to 1)
C2D30: Diagnostic test (n=2)
1.0
(1 to 1)
Baseline cycle 3: Seen any doctor (n=1)
1.0
(1 to 1)
Baseline cycle 3: Diagnostic test (n=2)
1.0
(1 to 1)
C3D7: Seen any doctor (n=1)
1.0
(1 to 1)
C3D7: Outpatient surgery (n=1)
1.0
(1 to 1)
C3D30: Seen any doctor (n=2)
2.5
(2 to 3)
C3D30: Received any therapy (n=1)
1.0
(1 to 1)
C3D30: Outpatient surgery (n=1)
3.0
(3 to 3)
Baseline cycle 4: Seen any doctor (n=1)
2.0
(2 to 2)
C4D7: Received any therapy (n=2)
3.0
(3 to 3)
C4D30: Seen any doctor (n=1)
1.0
(1 to 1)
C4D30: Received any therapy (n=1)
6.0
(6 to 6)
Follow-up Day 90: Seen any doctor (n=10)
1.5
(1 to 3)
Follow-up Day 90: Received any therapy (n=8)
2.0
(1 to 45)
Follow-up Day 90: Treated in emergency room (n=8)
1.0
(1 to 2)
Follow-up Day 90: Outpatient surgery (n=11)
1.0
(1 to 3)
Follow-up Day 90: Hospitalization (n=4)
1.0
(1 to 1)
Follow-up Day 90: Diagnostic test (n=4)
1.0
(1 to 4)
Follow-up Day 180: Seen any doctor (n=4)
1.5
(1 to 3)
Follow-up Day 180: Received any therapy (n=3)
3.0
(2 to 22)
Follow-up Day 180: Treated in emergency room (n=8)
1.0
(1 to 3)
Follow-up Day 180: Outpatient surgery (n=9)
1.0
(1 to 5)
Follow-up Day 180: Hospitalization (n=6)
1.0
(1 to 2)
Follow-up Day 180: Diagnostic test (n=1)
1.0
(1 to 1)
32.Secondary Outcome
Title Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Hide Description Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.
Time Frame Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. ‘Number of participants’ analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of days was not analyzed for participants who responded that they did not perform the event.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: days
Baseline cycle 1: Required aids/devices (n=1)
8.0
(8 to 8)
C1D7: Hospitalization (n=1)
2.0
(2 to 2)
C1D7: Required aids/devices (n=1)
2.0
(2 to 2)
C1D30: Hospitalization (n=2)
8.5
(7 to 10)
C1D30: Required aids/devices (n=1)
20.0
(20 to 20)
C2D7: Required aids/devices (n=1)
8.0
(8 to 8)
C2D30: Hospitalization (n=1)
3.0
(3 to 3)
C2D30: Required aids/devices(n=1)
6.0
(6 to 6)
C3D30: Required aids/devices (n=1)
5.0
(5 to 5)
Baseline cycle 4: Required aids/devices (n=1)
5.0
(5 to 5)
Follow-up: Day 90: Hospitalization (n=4)
9.5
(2 to 21)
Follow-up: Day 90: In nursing home (n=1)
21.0
(21 to 21)
Follow-up: Day 90: Required aids/devices(n=1)
16.0
(16 to 16)
Follow-up: Day 180: Hospitalization (n=6)
2.5
(1 to 47)
Follow-up: Day 180: Required aids/devices (n=1)
2.0
(2 to 2)
33.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Hide Description Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.
Time Frame Screening up to Day 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants who received at least 1 injection of Xiapex.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Measure Type: Number
Unit of Measure: participants
0
34.Other Pre-specified Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy[if urine tested positive for blood or protein]).
Time Frame Screening up to Day 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants who received at least 1 injection of Xiapex.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 254
Measure Type: Number
Unit of Measure: participants
48
35.Other Pre-specified Outcome
Title Number of Participants With Anti-Drug Antibody (ADA)
Hide Description Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Time Frame Screening, Follow-up Day 180 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Xiapex
Hide Arm/Group Description:
A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Number of Participants Analyzed 248
Measure Type: Number
Unit of Measure: participants
Screening: AUX-I Antibodies (n=248) 6
Screening: AUX-II Antibodies (n=248) 3
Follow-up Day 180: AUX-I Antibodies (n=239) 220
Follow-up Day 180: AUX-II Antibodies (n=239) 215
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Xiapex
Hide Arm/Group Description A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
All-Cause Mortality
Xiapex
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Xiapex
Affected / at Risk (%)
Total   12/254 (4.72%) 
Cardiac disorders   
Aortic valve disease mixed * 1  1/254 (0.39%) 
Gastrointestinal disorders   
Ileus paralytic * 1  1/254 (0.39%) 
Intestinal haemorrhage * 1  1/254 (0.39%) 
Oesophageal stenosis * 1  1/254 (0.39%) 
Oesophageal ulcer * 1  1/254 (0.39%) 
Infections and infestations   
Groin abscess * 1  1/254 (0.39%) 
Groin infection * 1  1/254 (0.39%) 
Postoperative wound infection * 1  1/254 (0.39%) 
Injury, poisoning and procedural complications   
Femoral neck fracture * 1  1/254 (0.39%) 
Road traffic accident * 1  1/254 (0.39%) 
Investigations   
Transaminases increased * 1  1/254 (0.39%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/254 (0.39%) 
Pain in extremity * 1  1/254 (0.39%) 
Rotator cuff syndrome * 1  1/254 (0.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer * 1  1/254 (0.39%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/254 (0.39%) 
Epistaxis * 1  1/254 (0.39%) 
Pneumothorax * 1  1/254 (0.39%) 
Surgical and medical procedures   
Dupuytren`s contracture operation * 1  1/254 (0.39%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Xiapex
Affected / at Risk (%)
Total   212/254 (83.46%) 
Blood and lymphatic system disorders   
Lymphadenopathy * 1  17/254 (6.69%) 
Lymph Node Pain * 1  6/254 (2.36%) 
General disorders   
Oedema Peripheral * 1  111/254 (43.70%) 
Injection Site Pain * 1  53/254 (20.87%) 
Injection Site Haematoma * 1  39/254 (15.35%) 
Injection Site Swelling * 1  23/254 (9.06%) 
Injection Site Oedema * 1  20/254 (7.87%) 
Tenderness * 1  15/254 (5.91%) 
Axillary Pain * 1  10/254 (3.94%) 
Injection Site Vesicles * 1  10/254 (3.94%) 
Injection Site Haemorrhage * 1  9/254 (3.54%) 
Injection Site Erythema * 1  8/254 (3.15%) 
Malaise * 1  6/254 (2.36%) 
Infections and infestations   
Nasopharyngitis * 1  7/254 (2.76%) 
Injury, poisoning and procedural complications   
Skin Laceration * 1  37/254 (14.57%) 
Contusion * 1  34/254 (13.39%) 
Procedural Pain * 1  31/254 (12.20%) 
Surgical Skin Tear * 1  18/254 (7.09%) 
Post Procedural Swelling * 1  9/254 (3.54%) 
Post Procedural Complication * 1  8/254 (3.15%) 
Investigations   
Blood Glucose Increased * 1  6/254 (2.36%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  65/254 (25.59%) 
Arthralgia * 1  16/254 (6.30%) 
Joint Swelling * 1  11/254 (4.33%) 
Musculoskeletal Pain * 1  6/254 (2.36%) 
Nervous system disorders   
Paraesthesia * 1  8/254 (3.15%) 
Headache * 1  7/254 (2.76%) 
Skin and subcutaneous tissue disorders   
Ecchymosis * 1  17/254 (6.69%) 
Pruritus * 1  13/254 (5.12%) 
Blood Blister * 1  12/254 (4.72%) 
Vascular disorders   
Haematoma * 1  49/254 (19.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Results were not reported for fifth injection as no finger received 5 injections.Results are reported for 'number of days of concomitant pain medication' as 'amount of pain medication' was interpreted as total number of days with pain medication use.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01229436     History of Changes
Other Study ID Numbers: B1531002
First Submitted: October 26, 2010
First Posted: October 27, 2010
Results First Submitted: October 29, 2013
Results First Posted: March 17, 2014
Last Update Posted: March 17, 2014