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Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease (CORD-II)

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ClinicalTrials.gov Identifier: NCT00533273
Recruitment Status : Completed
First Posted : September 21, 2007
Results First Posted : October 22, 2010
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Advanced Dupuytren's Disease
Intervention Biological: collagenase clostridium histolyticum
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description Collagenase clostridium histolyticum 0.58 mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints Placebo (Sucrose and Tris) injection
Period Title: Double-blind
Started 45 21
Completed 45 19
Not Completed 0 2
Reason Not Completed
Withdrew consent             0             2
Period Title: Open-label
Started 64 [1] 0 [2]
Completed 58 0
Not Completed 6 0
Reason Not Completed
Withdrawal by Subject             6             0
[1]
open-label was extension of double-blind; 64 of 66 patients continued into open-label
[2]
no placebo - this phase was open label
Arm/Group Title AA4500 0.58 mg Placebo Total
Hide Arm/Group Description Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints Placebo (Sucrose and Tris) injection Total of all reporting groups
Overall Number of Baseline Participants 45 21 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 21 participants 66 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  55.6%
9
  42.9%
34
  51.5%
>=65 years
20
  44.4%
12
  57.1%
32
  48.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 21 participants 66 participants
63.0  (7.8) 65.5  (11.1) 63.8  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 21 participants 66 participants
Female
6
  13.3%
4
  19.0%
10
  15.2%
Male
39
  86.7%
17
  81.0%
56
  84.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 45 participants 21 participants 66 participants
45 21 66
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 45 participants 21 participants 66 participants
45 21 66
1.Primary Outcome
Title Reduction in Primary Joint Contracture to 5° or Less
Hide Description Successfully treated or clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Time Frame Within 30 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Measure Type: Number
Unit of Measure: Percentage of Joints
44.4 4.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500 0.58 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Clinical Improvement in Primary Joint After the Last Injection
Hide Description Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Time Frame Baseline, Within 30 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Measure Type: Number
Unit of Measure: Percentage of Joints
77.8 14.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500 0.58 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection
Hide Description Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture
Time Frame Baseline, Day 30 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Mean (Standard Deviation)
Unit of Measure: Percentage of change
70.5  (29.21) 13.6  (26.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500 0.58 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline Range of Motion in Primary Joint After the Last Injection
Hide Description Change in degree of range of motion in primary joint measured as last available post-injection range of motion − baseline range of motion
Time Frame Baseline, Day 30 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Mean (Standard Deviation)
Unit of Measure: Degrees
35.4  (17.77) 7.6  (14.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500 0.58 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Time to Reach Clinical Success in Primary Joint
Hide Description Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories
Time Frame Within 30 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Measure Type: Number
Unit of Measure: Percentage of Joints
Injection 1, Day 1 2.2 0.0
Injection 1, Day 7 6.7 4.8
Injection 1, Day 30 17.8 0.0
Injection 2, Day 1 0.0 0.0
Injection 2, Day 7 4.4 0.0
Injection 2, Day 30 8.9 0.0
Injection 3, Day 1 4.4 0.0
Injection 3, Day 7 0.0 0.0
Injection 3, Day 30 0.0 0.0
Did not reach Clinical Success 55.6 95.2
6.Secondary Outcome
Title Clinical Success in Primary Joint After the First Injection
Hide Description Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Time Frame Within 30 days after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Measure Type: Number
Unit of Measure: Percentage of Joints
26.7 4.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500 0.58 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .014
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Clinical Improvement in Primary Joint After the First Injection
Hide Description Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Time Frame Baseline, Within 30 days after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Measure Type: Number
Unit of Measure: Percentage of Joints
60.0 4.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500 0.58 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Percent Reduction From Baseline Contracture of Primary Joint After the First Injection
Hide Description Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture − last available post-injection contracture prior to next injection)/baseline contracture
Time Frame Baseline, Day 30 after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Mean (Standard Deviation)
Unit of Measure: Percentage of change
58.5  (31.74) 6.0  (20.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500 0.58 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline Range of Motion in Primary Joint After the First Injection
Hide Description Change in degree of range of motion in primary joint measured as last available post-injection range of motion prior to the next injection − baseline range of motion
Time Frame Baseline, Day 30 after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 injection
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Placebo (Sucrose and Tris) injection
Overall Number of Participants Analyzed 45 21
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
45 21
Mean (Standard Deviation)
Unit of Measure: Degrees
28.6  (17.41) 3.6  (9.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500 0.58 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Reduction in Non-primary Joint Contracture to 5° or Less After the Last Injection
Hide Description Successfully treated or clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Time Frame Within 30 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Measure Type: Number
Unit of Measure: Percentage of Joints
53.9
11.Secondary Outcome
Title Clinical Improvement in Non-Primary Joint After the Last Injection
Hide Description Clinical improvement in non-primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Time Frame Baseline, Within 30 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Measure Type: Number
Unit of Measure: Percentage of Joints
70.8
12.Secondary Outcome
Title Percent Reduction From Baseline Contracture of Non-Primary Joint After the Last Injection
Hide Description Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture
Time Frame Baseline, Day 30 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Mean (Standard Deviation)
Unit of Measure: Percentage of change
66.4  (34.63)
13.Secondary Outcome
Title Change From Baseline Range of Motion in Non-Primary Joint After the Last Injection
Hide Description Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion − baseline range of motion
Time Frame Baseline, Day 30 after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Mean (Standard Deviation)
Unit of Measure: Degrees
25.2  (16.80)
14.Secondary Outcome
Title Time to Reach Clinical Success in Non-Primary Joint
Hide Description Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories
Time Frame Within 30 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Measure Type: Number
Unit of Measure: Percentage of Joints
Injection 1, Day 1 6.7
Injection 1, Day 7 18.0
Injection 1, Day 30 11.2
Injection 2, Day 0 0.0
Injection 2, Day 1 9.0
Injection 2, Day 7 2.2
Injection 2, Day 30 4.5
Injection 3, Day 0 0.0
Injection 3, Day 1 0.0
Injection 3, Day 7 0.0
Injection 3, Day 30 2.2
Did not reach Clinical Success 46.1
15.Secondary Outcome
Title Clinical Success in Non-Primary Joint After the First Injection
Hide Description Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Time Frame Within 30 days after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Measure Type: Number
Unit of Measure: Percentage of Joints
36.0
16.Secondary Outcome
Title Clinical Improvement in Non-Primary Joint After the First Injection
Hide Description Clinical improvement in non-primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Time Frame Baseline, Within 30 days after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Measure Type: Number
Unit of Measure: Percentage of Joints
58.4
17.Secondary Outcome
Title Percent Reduction From Baseline Contracture of Non-Primary Joint After the First Injection
Hide Description Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture − last available post-injection contracture prior to next injection)/baseline contracture
Time Frame Baseline, Day 30 after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Mean (Standard Deviation)
Unit of Measure: Percentage of change
54.7  (38.37)
18.Secondary Outcome
Title Change From Baseline Range of Motion in Non-Primary Joint After the First Injection
Hide Description Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion prior to the next injection − baseline range of motion
Time Frame Baseline, Day 30 after first injection
Hide Outcome Measure Data
Hide Analysis Population Description
Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period
Arm/Group Title AA4500 0.58 mg
Hide Arm/Group Description:
Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
89
Mean (Standard Deviation)
Unit of Measure: Degrees
20.5  (17.52)
Time Frame Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study.
Adverse Event Reporting Description This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide & XIAFLEX Prescribing Information (see links above)
 
Arm/Group Title AA4500 0.58 mg Placebo
Hide Arm/Group Description collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints Placebo injection is comprised of sucrose and Tris
All-Cause Mortality
AA4500 0.58 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AA4500 0.58 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/63 (11.11%)      1/21 (4.76%)    
Cardiac disorders     
Atrial fibrillation * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Eye disorders     
Orbital cyst * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Infections and infestations     
Pneumonia * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications     
Ligament injury * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Dupuytren's contracture * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Nervous system disorders     
Sensory disturbance * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Social circumstances     
Inguinal hernia repair * 1  0/63 (0.00%)  0 1/21 (4.76%)  1
Surgical and medical procedures     
Abdominal hernia repair * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Dupuytren's contracture operation * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
Umbilical hernia repair * 1  1/63 (1.59%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
AA4500 0.58 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   63/63 (100.00%)      10/21 (47.62%)    
Blood and lymphatic system disorders     
Lymphadenopathy * 1  13/63 (20.63%)  21 0/21 (0.00%)  0
General disorders     
Injection site haemorrhage * 1  27/63 (42.86%)  76 0/21 (0.00%)  0
Injection site pain * 1  28/63 (44.44%)  61 2/21 (9.52%)  3
Injection site swelling * 1  23/63 (36.51%)  55 3/21 (14.29%)  3
Oedema peripheral * 1  54/63 (85.71%)  163 2/21 (9.52%)  3
Tenderness * 1  20/63 (31.75%)  24 0/21 (0.00%)  0
Injection site vesicles * 1  5/63 (7.94%)  5 0/21 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection * 1  4/63 (6.35%)  5 2/21 (9.52%)  2
Lower respiratory tract infection * 1  4/63 (6.35%)  4 0/21 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion * 1  46/63 (73.02%)  136 2/21 (9.52%)  4
Musculoskeletal and connective tissue disorders     
Axillary pain * 1  8/63 (12.70%)  11 0/21 (0.00%)  0
Pain in extremity * 1  36/63 (57.14%)  82 3/21 (14.29%)  4
Nervous system disorders     
Dizziness * 1  5/63 (7.94%)  5 0/21 (0.00%)  0
Headache * 1  2/63 (3.17%)  2 2/21 (9.52%)  3
Paraesthesia * 1  5/63 (7.94%)  6 1/21 (4.76%)  3
Renal and urinary disorders     
Haematuria * 1  2/63 (3.17%)  2 2/21 (9.52%)  2
Skin and subcutaneous tissue disorders     
Pruritus * 1  13/63 (20.63%)  26 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
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.
Auxilium Pharmaceuticals, Inc. agreements may vary with individual investigators but will not prohibit any investigator from publishing. Auxilium supports the publication of results from all centers of a multicenter trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals Inc.
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00533273     History of Changes
Other Study ID Numbers: AUX CC 859
First Submitted: September 20, 2007
First Posted: September 21, 2007
Results First Submitted: September 24, 2010
Results First Posted: October 22, 2010
Last Update Posted: December 2, 2017