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Trial record 18 of 75 for:    "Collagen Disease" | "Triamcinolone"

Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT02468583
Recruitment Status : Terminated
First Posted : June 11, 2015
Results First Posted : December 21, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Post-traumatic Osteoarthritis of the Knee
Interventions Drug: FX006 32 mg
Drug: TCA IR 40 mg
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description 3 subjects received FX006 32 mg as a single 5 mL IA injection 3 subjects received TCA IR 40 mg as a single 1 mL IA injection
Period Title: Overall Study
Started 3 3
Completed 3 3
Not Completed 0 0
Arm/Group Title FX006 32 mg TCA IR 40 mg Total
Hide Arm/Group Description FX006: Single 5 mL IA injection TCA IR: Single 1 mL IA injection Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
43
(36 to 49)
40
(37 to 47)
42
(36 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
6
 100.0%
1.Primary Outcome
Title Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10
Hide Description The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame 5-10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12
Hide Description The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Hide Description [Not Specified]
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week
Hide Description [Not Specified]
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Hide Description [Not Specified]
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title WOMAC A (Pain Subscale)
Hide Description change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title WOMAC A1 (Pain on Walking Question)
Hide Description change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title WOMAC B (Stiffness)
Hide Description change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title WOMAC C (Function)
Hide Description change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title WOMAC (Total):
Hide Description change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Knee Injury and Osteoarthritis Score (KOOS)
Hide Description change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Time to Onset of Pain Relief
Hide Description Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing >30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline
Time Frame Baseline to >30% improvement
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Average Weekly and Total Consumption of Rescue Medication
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events were collected following IA administration through the final study visit at week 12.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FX006 32 mg TCA IR 40 mg
Hide Arm/Group Description FX006: Single 5 mL IA injection TCA IR: Single 3 mL IA injection
All-Cause Mortality
FX006 32 mg TCA IR 40 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FX006 32 mg TCA IR 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FX006 32 mg TCA IR 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      2/3 (66.67%)    
Gastrointestinal disorders     
Haemorrhoids   0/3 (0.00%)  0 1/3 (33.33%)  1
Infections and infestations     
Tooth Infection   1/3 (33.33%)  1 0/3 (0.00%)  0
Bronchitis   0/3 (0.00%)  0 1/3 (33.33%)  1
Blood triglycerides increased   0/3 (0.00%)  0 1/3 (33.33%)  1
Injury, poisoning and procedural complications     
Contusion   1/3 (33.33%)  1 0/3 (0.00%)  0
Investigations     
Blood cholesterol increased   0/3 (0.00%)  0 1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia   1/3 (33.33%)  1 1/3 (33.33%)  1
Nervous system disorders     
Headache   2/3 (66.67%)  2 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
This study was terminated early with only 5% of the planned study population enrolled, efficacy data were not analyzed.
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.
Results Point of Contact
Name/Title: Scott Kelley, VP of Medical Affairs
Organization: Flexion Therapeutics
Phone: 781-305-7142
Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02468583     History of Changes
Other Study ID Numbers: FX006-2014-007
First Submitted: May 27, 2015
First Posted: June 11, 2015
Results First Submitted: November 6, 2017
Results First Posted: December 21, 2017
Last Update Posted: August 29, 2018