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Trial record 54 of 75 for:    "Collagen Disease" | "Triamcinolone"

Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02116972
Recruitment Status : Completed
First Posted : April 17, 2014
Results First Posted : March 20, 2018
Last Update Posted : March 20, 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 Osteoarthritis of the Knee
Interventions Drug: FX006 32 mg
Drug: Placebo
Drug: FX006 16 mg
Enrollment 310
Recruitment Details Patients were screened for study eligibility at 48 study centers in the United States (US) and Canada. Enrollment took approximately 7 months.
Pre-assignment Details Subjects were screened within 21 days of being randomized
Arm/Group Title FX006 16 mg FX006 32 mg Placebo
Hide Arm/Group Description 102 subjects received FX006 16 mg a single 5 mL IA injection 104 subjects received FX006 32 mg a single 5 mL IA injection 100 subjects received normal saline as a single 5 mL IA injection
Period Title: Overall Study
Started 102 104 104
Completed 83 87 85
Not Completed 19 17 19
Reason Not Completed
Adverse Event             4             4             1
Withdrawal by Subject             1             1             5
Protocol Violation             1             0             1
Lost to Follow-up             4             3             1
Lack of Efficacy             6             6             5
scheduling conflicts and relocation             3             3             6
Arm/Group Title FX006 16 mg FX006 32 mg Normal Saline Total
Hide Arm/Group Description

Single intra-articular injection

FX006: Single intra-articular injection

Single intra-articular injection

FX006: Single intra-articular injection

Single intra-articular injection

Normal saline: Single intra-articular injection

Total of all reporting groups
Overall Number of Baseline Participants 102 104 100 306
Hide Baseline Analysis Population Description
A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 104 participants 100 participants 306 participants
58.2  (8.34) 58.7  (8.06) 59.7  (8.23) 58.8  (8.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 104 participants 100 participants 306 participants
Female
62
  60.8%
51
  49.0%
61
  61.0%
174
  56.9%
Male
40
  39.2%
53
  51.0%
39
  39.0%
132
  43.1%
1.Primary Outcome
Title Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo
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 Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.08  (0.229) -2.50  (0.238)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FX006 32 mg, Placebo
Comments The step-down testing procedure to control for multiplicity would be voided if the primary endpoint is not met and analyses proceeded for exploratory purposes.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0821
Comments [Not Specified]
Method Logitudinal mixed effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-1.22 to 0.07
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 12 for WOMAC C (Function Subscale)
Hide Description The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.01  (0.083) -0.79  (0.087)
3.Secondary Outcome
Title Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)
Hide Description The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.6  (0.14) 2.7  (0.14)
4.Secondary Outcome
Title Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores
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 Baseline and Weeks 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized patients who received study drug.
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 16 Number Analyzed 97 participants 86 participants
-2.83  (0.2224) -2.46  (0.234)
Week 20 Number Analyzed 91 participants 82 participants
-2.81  (0.233) -2.34  (0.244)
Week 24 Number Analyzed 78 participants 68 participants
-2.51  (0.241) -2.24  (0.252)
5.Other Pre-specified Outcome
Title Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria
Hide Description Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.
Time Frame Weeks 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Percent of responders according to Outcomes Measures in OMERACT-OARSI strict criteria for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 104 participants 98 participants
75
  72.1%
51
  52.0%
Week 8 Number Analyzed 104 participants 94 participants
73
  70.2%
58
  61.7%
Week 12 Number Analyzed 101 participants 92 participants
70
  69.3%
57
  62.0%
6.Other Pre-specified Outcome
Title Change From Baseline to Week 12 for WOMAC C (Function Subscale)
Hide Description The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5- point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 16 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 102 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.83  (0.085) -0.79  (0.087)
7.Other Pre-specified Outcome
Title Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)
Hide Description The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 16 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 102 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.5  (0.14) 2.7  (0.14)
8.Other Pre-specified Outcome
Title Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores
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."Weeks 12, 16, 20, and 24 are specified as the primary and secondary endpoints for the 32 mg group and the placebo group
Time Frame Baseline and Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized patients who received study drug.
Arm/Group Title FX006 16 mg FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 102 104 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 1 Number Analyzed 100 participants 103 participants 100 participants
-2.04  (0.177) -1.96  (0.175) -1.24  (0.178)
Week 2 Number Analyzed 101 participants 103 participants 99 participants
-2.88  (0.218) -2.75  (0.216) -1.65  (0.220)
Week 3 Number Analyzed 100 participants 103 participants 94 participants
-2.90  (0.228) -2.91  (0.226) -1.74  (0.231)
Week 4 Number Analyzed 98 participants 101 participants 93 participants
-3.05  (0.228) -3.20  (0.226) -1.84  (0.232)
Week 5 Number Analyzed 97 participants 100 participants 93 participants
-3.28  (0.222) -3.39  (0.219) -2.05  (0.225)
Week 6 Number Analyzed 97 participants 101 participants 91 participants
-3.27  (0.225) -3.29  (0.222) -2.20  (0.229)
Week 7 Number Analyzed 97 participants 102 participants 92 participants
-3.14  (0.233) -3.13  (0.230) -2.28  (0.237)
Week 8 Number Analyzed 95 participants 101 participants 91 participants
-3.08  (0.237) -3.04  (0.234) -2.33  (0.242)
Week 9 Number Analyzed 91 participants 98 participants 92 participants
-3.09  (0.233) -3.24  (0.229) -2.39  (0.237)
Week 10 Number Analyzed 92 participants 98 participants 90 participants
-2.88  (0.229) -3.17  (0.224) -2.44  (0.233)
Week 11 Number Analyzed 90 participants 96 participants 90 participants
-2.78  (0.234) -3.18  (0.229) -2.48  (0.238)
Week 12 Number Analyzed 90 participants 96 participants 89 participants
-2.59  (0.234) -3.08  (0.229) -2.50  (0.238)
Week 13 Number Analyzed 90 participants 96 participants 88 participants
-2.68  (0.234) -3.12  (0.229) -2.43  (0.239)
Week 14 Number Analyzed 89 participants 96 participants 85 participants
-2.38  (0.235) -2.83  (0.229) -2.48  (0.239)
Week 15 Number Analyzed 86 participants 95 participants 88 participants
-2.38  (0.225) -2.91  (0.219) -2.44  (0.229)
Week 16 Number Analyzed 87 participants 97 participants 86 participants
-2.30  (0.231) -2.83  (0.224) -2.46  (0.234)
Week 17 Number Analyzed 82 participants 96 participants 88 participants
-2.32  (0.237) -2.71  (0.229) -2.41  (0.240)
Week 18 Number Analyzed 82 participants 91 participants 86 participants
-2.32  (0.240) -2.73  (0.232) -2.34  (0.242)
Week 19 Number Analyzed 82 participants 91 participants 85 participants
-2.27  (0.241) -2.76  (0.233) -2.28  (0.243)
Week 20 Number Analyzed 81 participants 91 participants 82 participants
-2.27  (0.241) -2.81  (0.233) -2.34  (0.244)
Week 21 Number Analyzed 76 participants 85 participants 76 participants
-2.21  (0.246) -2.71  (0.237) -2.38  (0.248)
Week 22 Number Analyzed 72 participants 81 participants 71 participants
-2.41  (0.249) -2.53  (0.240) -2.30  (0.251)
Week 23 Number Analyzed 72 participants 78 participants 71 participants
-2.33  (0.258) -2.40  (0.249) -2.25  (0.260)
Week 24 Number Analyzed 71 participants 78 participants 68 participants
-2.38  (0.249) -2.51  (0.241) -2.24  (0.252)
9.Other Pre-specified Outcome
Title Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function
Hide Description The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame Baseline and Weeks 4, 8, 16, 20 and 24 (Week 12 data is represented in the secondary outcome measure)
Hide Outcome Measure Data
Hide Analysis Population Description
Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 4 Number Analyzed 104 participants 95 participants
-1.16  (0.079) -0.66  (0.082)
Week 8 Number Analyzed 103 participants 93 participants
-1.09  (0.082) -0.74  (0.085)
Week 16 Number Analyzed 95 participants 87 participants
-0.94  (0.083) -0.84  (0.086)
Week 20 Number Analyzed 92 participants 87 participants
-0.87  (0.082) -0.84  (0.085)
Week 24 Number Analyzed 80 participants 76 participants
-0.89  (0.083) -0.80  (0.086)
10.Other Pre-specified Outcome
Title Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain
Hide Description The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Change from baseline to each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A pain for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 4 Number Analyzed 104 participants 95 participants
-1.11  (0.080) -0.64  (0.082)
Week 8 Number Analyzed 104 participants 93 participants
-1.09  (0.083) -0.71  (0.087)
Week 12 Number Analyzed 100 participants 90 participants
-0.98  (0.080) -0.81  (0.083)
Week 16 Number Analyzed 95 participants 87 participants
-0.95  (0.083) -0.80  (0.087)
Week 20 Number Analyzed 92 participants 87 participants
-0.89  (0.083) -0.84  (0.086)
Week 24 Number Analyzed 80 participants 76 participants
-0.91  (0.084) -0.78  (0.086)
11.Other Pre-specified Outcome
Title Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC
Hide Description The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Time Frame Baseline and Weeks 4, 8, 16, 20, and 24 (Week 12 data reported in secondary outcome measure)
Hide Outcome Measure Data
Hide Analysis Population Description
Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in PGIC for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 4 Number Analyzed 104 participants 94 participants
2.2  (0.13) 3.0  (0.13)
Week 8 Number Analyzed 104 participants 93 participants
2.4  (0.14) 2.8  (0.14)
Week 16 Number Analyzed 95 participants 87 participants
2.8  (0.16) 2.7  (0.16)
Week 20 Number Analyzed 92 participants 87 participants
2.9  (0.15) 2.8  (0.16)
Week 24 Number Analyzed 80 participants 76 participants
2.7  (0.16) 3.1  (0.16)
12.Other Pre-specified Outcome
Title Proportion of Patients Experiencing a >20%, 30% and 50% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Week 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
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Time to Onset of Pain Relief
Hide Description Time to onset of pain relief in days is defined as the time from administration of study treatment to the first pain assessment showing >30% improvement from the weekly average daily pain score at baseline.
Time Frame Baseline up to 24 Weeks after administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Time to onset of pain relief for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.
Arm/Group Title FX006 32 mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
Overall Number of Participants Analyzed 104 100
Median (95% Confidence Interval)
Unit of Measure: days
4
(3 to 8)
8
(5 to 17)
Time Frame Adverse Events were collected following IA administration through the final study visit.
Adverse Event Reporting Description A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.
 
Arm/Group Title FX006 16 mg FX006 32 mg Placebo
Hide Arm/Group Description Single 5 mL IA injection Single 5 mL IA injection Single 5 mL IA injection
All-Cause Mortality
FX006 16 mg FX006 32 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)      0/104 (0.00%)      0/100 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FX006 16 mg FX006 32 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/102 (0.98%)      3/104 (2.88%)      0/100 (0.00%)    
Cardiac disorders       
Myocardial Infarction  1  0/102 (0.00%)  0 1/104 (0.96%)  1 0/100 (0.00%)  0
Injury, poisoning and procedural complications       
Femur Fracture  1  1/102 (0.98%)  1 0/104 (0.00%)  0 0/100 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  0/102 (0.00%)  0 1/104 (0.96%)  1 0/100 (0.00%)  0
Rheumatoid Arthritis  1  0/102 (0.00%)  0 1/104 (0.96%)  1 0/100 (0.00%)  0
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FX006 16 mg FX006 32 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/102 (13.73%)      13/104 (12.50%)      21/100 (21.00%)    
Musculoskeletal and connective tissue disorders       
Arthralgia  1  10/102 (9.80%)  10 8/104 (7.69%)  8 16/100 (16.00%)  16
Joint Swelling  1  4/102 (3.92%)  4 5/104 (4.81%)  5 5/100 (5.00%)  5
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Subsequent to completion of clinical studies extensive testing was performed to assess the actual dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg and from FX006 20 mg vial is 16 mg.
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: NCT02116972     History of Changes
Other Study ID Numbers: FX006-2014-006
First Submitted: April 15, 2014
First Posted: April 17, 2014
Results First Submitted: November 2, 2017
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018