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Trial record 43 of 75 for:    "Collagen Disease" | "Triamcinolone"

Study of FX006 for the Treatment of Pain 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: NCT02357459
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : February 1, 2018
Last Update Posted : February 7, 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
Drug: Placebo
Drug: TCA IR 40
Enrollment 486
Recruitment Details This study took place at 41 centers across the United States, Canada, Australia, New Zealand, Hong Kong, Denmark, Romania, Estonia and Lithuania. Enrollment took approximately 6 months
Pre-assignment Details Subjects were screened within 21 days of being randomized.
Arm/Group Title FX006 32mg Placebo TCA IR 40 mg
Hide Arm/Group Description 161 subjects received FX006 32 mg as a single 5 mL IA injection 162 subjects received normal saline as a single 5 mL IA injection. 161 subjects received TCA IR 40 mg as a single 1 mL IA injection
Period Title: Overall Study
Started 161 163 162
Completed 144 149 150
Not Completed 17 14 12
Reason Not Completed
Adverse Event             0             1             1
Withdrawal by Subject             5             3             3
Physician Decision             0             2             0
Protocol Violation             1             1             0
Lost to Follow-up             1             3             0
Lack of Efficacy             7             4             4
Patient Relocated             2             0             0
Instruction from PCP             1             0             0
Incarceration             0             0             1
Pre-planned Knee surgery             0             0             2
Job Commitments             0             0             1
Arm/Group Title FX006 32mg Placebo TCA IR 40 mg Total
Hide Arm/Group Description FX006: Single 5 mL IA injection Normal Saline: Single 5 mL IA injection TCA IR: Single 1 mL IA injection Total of all reporting groups
Overall Number of Baseline Participants 161 162 161 484
Hide Baseline Analysis Population Description
A total of 486 patients were randomized in the study. Two patients, 1 each in the placebo group and 40 mg TCA IR group, were randomized and not treated. These 2 patients were not included in the FAS, Safety, or PP populations.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 162 participants 161 participants 484 participants
61.5  (9.52) 62.4  (8.89) 62.3  (10.08) 62.1  (9.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 162 participants 161 participants 484 participants
Female
103
  64.0%
96
  59.3%
97
  60.2%
296
  61.2%
Male
58
  36.0%
66
  40.7%
64
  39.8%
188
  38.8%
1.Primary Outcome
Title Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) 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 ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame Baseline and 12 Weeks
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 32mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection.
Overall Number of Participants Analyzed 161 162
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.12  (0.203) -2.14  (0.202)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FX006 32mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The analysis included all study weeks of data, and was not confined to only that at Baseline and Week 12. Descriptive statistics included number of observations, unadjusted mean, standard deviation, median, minimum and maximum, and baseline adjusted means from the mixed model. Treatment differences from control was presented, and estimated via least squares means from the analysis model along with 95% confidence intervals and associated 2-sided p-values.
Statistical Test of Hypothesis P-Value <0.0001
Comments The threshold for significance was <0.05.
Method longitudinal mixed repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-1.47 to -0.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo
Hide Description The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame Baseline to 12 Weeks
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 32mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection.
Overall Number of Participants Analyzed 161 162
Least Squares Mean (Standard Error)
Unit of Measure: ADP Pain Scores * Week
-247.3  (14.89) -145.3  (14.77)
3.Secondary Outcome
Title AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
Hide Description The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame Baseline to 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population 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 1 mL IA injection
Overall Number of Participants Analyzed 161 161
Least Squares Mean (Standard Error)
Unit of Measure: ADP Pain Scores * Week
-247.3  (14.89) -231.9  (14.85)
4.Secondary Outcome
Title Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
Hide Description The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame Baseline through 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population 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 1 mL IA injection
Overall Number of Participants Analyzed 161 161
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.12  (0.203) -2.86  (0.202)
5.Secondary Outcome
Title AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo
Hide Description The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for TCA IR 40 mg Relative to Placebo was not a pre-specified Secondary Outcome and therefore not reported
Arm/Group Title FX006 32mg Placebo
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection.
Overall Number of Participants Analyzed 161 162
Least Squares Mean (Standard Error)
Unit of Measure: ADP Pain Scores * Week
-432.5  (30.14) -297.0  (29.90)
6.Other Pre-specified Outcome
Title Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Hide Description The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame Weeks 1-11 & Weeks 13-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 161 162 161
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 1 -1.9  (0.202) -1.04  (0.200) -2.13  (0.201)
Week 2 -2.95  (0.202) -1.61  (0.201) -2.69  (0.201)
Week 3 -3.20  (0.202) -1.66  (0.201) -2.93  (0.202)
Week 4 -3.23  (0.202) -1.84  (0.200) -3.11  (0.202)
Week 5 -3.34  (0.202) -1.87  (0.201) -3.11  (0.202)
Week 6 -3.48  (0.202) -1.95  (0.201) -3.20  (0.202)
Week 7 -3.48  (0.202) -2.01  (0.201) -3.03  (0.202)
Week 8 -3.48  (0.202) -1.96  (0.202) -3.04  (0.202)
Week 9 -3.45  (0.202) -2.06  (0.202) -3.06  (0.202)
Week 10 -3.31  (0.202) -2.08  (0.201) -3.07  (0.202)
Week 11 -3.21  (0.203) -2.13  (0.202) -3.01  (0.202)
Week 13 -2.96  (0.203) -2.21  (0.202) -2.87  (0.202)
Week 14 -2.91  (0.203) -2.18  (0.202) -2.73  (0.202)
Week 15 -2.84  (0.204) -2.12  (0.202) -2.75  (0.202)
Week 16 -2.73  (0.204) -2.22  (0.203) -2.67  (0.203)
Week 17 -2.66  (0.204) -2.18  (0.203) -2.57  (0.203)
Week 18 -2.60  (0.204) -2.13  (0.203) -2.55  (.0203)
Week 19 -2.57  (0.204) -2.19  (0.203) -2.48  (0.202)
Week 20 -2.44  (0.204) -2.18  (0.203) -2.46  (0.202)
Week 21 -2.27  (0.204) -2.16  (0.203) -2.27  (0.203)
Week 22 -2.18  (0.205) -2.20  (0.204) -2.29  (0.203)
Week 23 -2.14  (0.205) -2.12  (0.204) -2.30  (0.203)
Week 24 -1.99  (0.205) -2.16  (0.203) -2.18  (0.203)
7.Other Pre-specified Outcome
Title Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
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 Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 161 162 161
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 4 -1.10  (0.068) -0.50  (0.067) -0.87  (0.067)
Week 8 -1.02  (0.071) -0.48  (0.070) -0.81  (0.070)
Week 12 -0.88  (0.071) -0.50  (0.071) -0.70  (0.070)
Week 16 -0.67  (0.072) -0.54  (0.071) -0.64  (0.071)
Week 20 -0.61  (0.069) -0.51  (0.069) -0.60  (0.068)
Week 24 -0.63  (0.070) -0.49  (0.070) -0.56  (0.069)
8.Other Pre-specified Outcome
Title Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
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 Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 161 162 161
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 4 -1.23  (0.079) -0.51  (0.077) -1.00  (0.078)
Week 8 -1.24  (0.078) -0.54  (0.077) -0.92  (0.077)
Week 12 -1.03  (0.079) -0.59  (0.078) -0.80  (0.078)
Week 16 -0.80  (0.080) -0.64  (0.080) -0.71  (0.079)
Week 20 -0.66  (0.078) -0.64  (0.078) -0.58  (0.077)
Week 24 -0.67  (0.080) -0.58  (0.079) -0.57  (0.079)
9.Other Pre-specified Outcome
Title Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
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 Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 161 162 161
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 4 -1.11  (.066) -0.51  (.065) -0.87  (.065)
Week 8 -1.09  (.068) -0.53  (.068) -0.80  (.068)
Week 12 -0.93  (.069) -0.56  (.068) -0.72  (.068)
Week 16 -0.69  (.069) -0.59  (.069) -0.62  (.069)
Week 20 -0.65  (.068) -0.56  (.068) -0.57  (.067)
Week 24 -0.59  (.069) -0.51  (.069) -0.54  (.068)
10.Other Pre-specified Outcome
Title Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24
Hide Description

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient’s opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL).

A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life.

Time Frame Weeks 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 136 144 134
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 4 23.50  (1.896) 8.93  (1.832) 15.60  (1.882)
Week 8 23.30  (1.907) 10.70  (1.856) 18.02  (1.891)
Week 12 21.19  (1.907) 12.22  (1.869) 15.77  (1.895)
Week 24 11.95  (1.923) 10.25  (1.878) 11.44  (1.906)
11.Other Pre-specified Outcome
Title Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)
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 Weeks 1-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 161 162 161
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1
66
  41.0%
42
  25.9%
81
  50.3%
Week 2
99
  61.5%
63
  38.9%
96
  59.6%
Week 3
109
  67.7%
61
  37.7%
101
  62.7%
Week 4
107
  66.5%
64
  39.5%
108
  67.1%
Week 5
106
  65.8%
69
  42.6%
109
  67.7%
Week 6
113
  70.2%
73
  45.1%
111
  68.9%
Week 7
112
  69.6%
75
  46.3%
112
  69.6%
Week 8
109
  67.7%
74
  45.7%
107
  66.5%
Week 9
107
  66.5%
79
  48.8%
109
  67.7%
Week 10
107
  66.5%
78
  48.1%
109
  67.7%
Week 11
107
  66.5%
78
  48.1%
105
  65.2%
Week 12
103
  64.0%
80
  49.4%
104
  64.6%
Week 13
97
  60.2%
81
  50.0%
106
  65.8%
Week 14
95
  59.0%
80
  49.4%
100
  62.1%
Week 15
88
  54.7%
79
  48.8%
97
  60.2%
Week 16
91
  56.5%
81
  50.0%
97
  60.2%
Week 17
84
  52.2%
82
  50.6%
86
  53.4%
Week 18
81
  50.3%
75
  46.3%
93
  57.8%
Week 19
86
  53.4%
78
  48.1%
88
  54.7%
Week 20
84
  52.2%
79
  48.8%
87
  54.0%
Week 21
82
  50.9%
76
  46.9%
83
  51.6%
Week 22
79
  49.1%
74
  45.7%
78
  48.4%
Week 23
77
  47.8%
79
  48.8%
84
  52.2%
Week 24
70
  43.5%
74
  45.7%
74
  46.0%
12.Other Pre-specified Outcome
Title Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)
Hide Description [Not Specified]
Time Frame Weeks 1-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 161 162 161
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1
39
  24.2%
21
  13.0%
57
  35.4%
Week 2
73
  45.3%
37
  22.8%
67
  41.6%
Week 3
81
  50.3%
40
  24.7%
77
  47.8%
Week 4
86
  53.4%
47
  29.0%
80
  49.7%
Week 5
85
  52.8%
51
  31.5%
80
  49.7%
Week 6
92
  57.1%
51
  31.5%
84
  52.2%
Week 7
97
  60.2%
49
  30.2%
85
  52.8%
Week 8
97
  60.2%
53
  32.7%
82
  50.9%
Week 9
91
  56.5%
55
  34.0%
83
  51.6%
Week 10
87
  54.0%
57
  35.2%
84
  52.2%
Week 11
83
  51.6%
60
  37.0%
80
  49.7%
Week 12
80
  49.7%
56
  34.6%
75
  46.6%
Week 13
79
  49.1%
57
  35.2%
77
  47.8%
Week 14
76
  47.2%
54
  33.3%
72
  44.7%
Week 15
73
  45.3%
55
  34.0%
70
  43.5%
Week 16
71
  44.1%
59
  36.4%
70
  43.5%
Week 17
69
  42.9%
59
  36.4%
67
  41.6%
Week 18
66
  41.0%
52
  32.1%
66
  41.0%
Week 19
64
  39.8%
54
  33.3%
67
  41.6%
Week 20
60
  37.3%
54
  33.3%
62
  38.5%
Week 21
56
  34.8%
54
  33.3%
61
  37.9%
Week 22
56
  34.8%
52
  32.1%
57
  35.4%
Week 23
51
  31.7%
54
  33.3%
63
  39.1%
Week 24
47
  29.2%
49
  30.2%
56
  34.8%
13.Other Pre-specified Outcome
Title Time to Onset of Pain Relief
Hide Description Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing >30% improvement from the weekly mean of the ADP scores at baseline
Time Frame Baseline to >30% improvement (measured up to 30 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 161 162 161
Median (95% Confidence Interval)
Unit of Measure: days
4
(4 to 5)
11
(7 to 24)
3
(3 to 5)
14.Other Pre-specified Outcome
Title Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Hide Description [Not Specified]
Time Frame Weeks 1-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FX006 32 mg Placebo TCA IR 40 mg
Hide Arm/Group Description:
FX006: Single 5 mL IA injection
Normal Saline: Single 5 mL IA injection
TCA IR: Single 1 mL IA injection
Overall Number of Participants Analyzed 161 162 161
Least Squares Mean (Standard Error)
Unit of Measure: tablets (1 tablet = 500 mg)
Week1 1.01  (0.140) 1.31  (0.139) 1.10  (0.140)
Week 2 0.69  (0.140) 1.39  (0.139) 1.00  (0.140)
Week 3 0.69  (0.140) 1.35  (0.139) 1.02  (0.140)
Week 4 0.58  (0.140) 1.28  (0.139) 0.90  (0.140)
Week 5 0.60  (0.140) 1.21  (0.139) 0.83  (0.140)
Week 6 0.56  (0.140) 1.24  (0.140) 0.87  (0.140)
Week 7 0.60  (0.141) 1.19  (0.140) 0.89  (0.140)
Week 8 0.63  (0.141) 1.24  (0.140) 0.85  (0.140)
Week 9 0.66  (0.141) 1.11  (0.140) 0.91  (0.140)
Week 10 0.67  (0.141) 1.21  (0.140) 1.01  (0.140)
Week 11 0.73  (0.141) 1.12  (0.140) 0.89  (0.140)
Week 12 0.62  (0.141) 1.13  (0.141) 0.93  (0.140)
Week 13 0.68  (0.141) 1.14  (0.141) 0.97  (0.140)
Week 14 0.67  (0.142) 1.18  (0.141) 0.98  (0.141)
Week 15 0.67  (0.142) 1.25  (0.141) 0.90  (0.141)
Week 16 0.71  (0.142) 1.15  (0.141) 0.93  (0.141)
Week 17 0.82  (0.142) 1.17  (0.141) 0.95  (0.141)
Week 18 0.87  (0.143) 1.15  (0.142) 1.08  (0.141)
Week 19 0.71  (0.142) 1.23  (0.141) 0.98  (0.141)
Week 20 0.69  (0.142) 1.22  (0.141) 0.94  (0.141)
Week 21 0.92  (0.143) 1.23  (0.142) 1.02  (0.141)
Week 22 0.98  (0.143) 1.21  (0.142) 0.98  (0.141)
Week 23 0.94  (0.143) 1.20  (0.142) 0.97  (0.141)
Week 24 0.95  (0.144) 1.18  (0.142) 1.04  (0.141)
Time Frame Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FX006 32mg Placebo TCA IR 40 mg
Hide Arm/Group Description FX006: Single 5 mL IA injection Normal Saline: Single 5 mL IA injection TCA IR: Single 1 mL IA injection
All-Cause Mortality
FX006 32mg Placebo TCA IR 40 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)      0/162 (0.00%)      0/161 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FX006 32mg Placebo TCA IR 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/161 (3.11%)      3/162 (1.85%)      4/161 (2.48%)    
Cardiac disorders       
Atrial Fibrillation  1  1/161 (0.62%)  1 0/162 (0.00%)  0 0/161 (0.00%)  0
Unstable Angina  1  0/161 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Gastrointestinal disorders       
Large Intestine Polyp  1  1/161 (0.62%)  1 0/162 (0.00%)  0 0/161 (0.00%)  0
Abdominal Hernia  1  0/161 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
Hepatobiliary disorders       
Cholangitis  1  0/161 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
Infections and infestations       
Pneumonia:  1  1/161 (0.62%)  1 0/162 (0.00%)  0 0/161 (0.00%)  0
Sepsis  1  0/161 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia:  1  1/161 (0.62%)  1 0/162 (0.00%)  0 0/161 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Rectal Cancer  1  1/161 (0.62%)  1 0/162 (0.00%)  0 0/161 (0.00%)  0
Nervous system disorders       
Seizure Tonic Clonic  1  0/161 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Dizziness  1  1/161 (0.62%)  1 0/162 (0.00%)  0 0/161 (0.00%)  0
Cerebrovascular Accident  1  0/161 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Psychiatric disorders       
Depression  1  0/161 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
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 32mg Placebo TCA IR 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/161 (31.68%)      49/162 (30.25%)      50/161 (31.06%)    
Infections and infestations       
Nasopharyngitis  1  5/161 (3.11%)  5 7/162 (4.32%)  7 11/161 (6.83%)  11
Musculoskeletal and connective tissue disorders       
Arthralgia  1  23/161 (14.29%)  23 20/162 (12.35%)  20 12/161 (7.45%)  12
Back Pain  1  9/161 (5.59%)  9 9/162 (5.56%)  9 12/161 (7.45%)  12
Vascular disorders       
Headache  1  14/161 (8.70%)  14 13/162 (8.02%)  13 15/161 (9.32%)  15
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 FX006 dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 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: NCT02357459     History of Changes
Other Study ID Numbers: FX006-2014-008
First Submitted: February 3, 2015
First Posted: February 6, 2015
Results First Submitted: October 24, 2017
Results First Posted: February 1, 2018
Last Update Posted: February 7, 2018