Trial Outcomes & Findings for Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee (NCT NCT02357459)
NCT ID: NCT02357459
Last Updated: 2024-01-24
Results Overview
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."
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
486 participants
Primary outcome timeframe
Baseline and 12 Weeks
Results posted on
2024-01-24
Participant Flow
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
Subjects were screened within 21 days of being randomized.
Participant milestones
| Measure |
FX006 32mg
161 subjects received FX006 32 mg as a single 5 mL IA injection
|
Placebo
162 subjects received normal saline as a single 5 mL IA injection.
|
TCA IR 40 mg
161 subjects received TCA IR 40 mg as a single 1 mL IA injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
161
|
163
|
162
|
|
Overall Study
COMPLETED
|
144
|
149
|
150
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
12
|
Reasons for withdrawal
| Measure |
FX006 32mg
161 subjects received FX006 32 mg as a single 5 mL IA injection
|
Placebo
162 subjects received normal saline as a single 5 mL IA injection.
|
TCA IR 40 mg
161 subjects received TCA IR 40 mg as a single 1 mL IA injection
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
3
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
4
|
4
|
|
Overall Study
Patient Relocated
|
2
|
0
|
0
|
|
Overall Study
Instruction from PCP
|
1
|
0
|
0
|
|
Overall Study
Incarceration
|
0
|
0
|
1
|
|
Overall Study
Pre-planned Knee surgery
|
0
|
0
|
2
|
|
Overall Study
Job Commitments
|
0
|
0
|
1
|
Baseline Characteristics
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 8.89 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 9.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
296 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm.
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."
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
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
|
-3.12 units on a scale
Standard Error 0.203
|
-2.14 units on a scale
Standard Error 0.202
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm
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."
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
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
|
-247.3 ADP Pain Scores * Week
Standard Error 14.89
|
-145.3 ADP Pain Scores * Week
Standard Error 14.77
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksThe 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."
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=161 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
|
-247.3 ADP Pain Scores * Week
Standard Error 14.89
|
-231.9 ADP Pain Scores * Week
Standard Error 14.85
|
—
|
SECONDARY outcome
Timeframe: Baseline through 12 WeeksThe 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."
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=161 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
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
|
-3.12 units on a scale
Standard Error 0.203
|
-2.86 units on a scale
Standard Error 0.202
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: 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
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."
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo
|
-432.5 ADP Pain Scores * Week
Standard Error 30.14
|
-297.0 ADP Pain Scores * Week
Standard Error 29.90
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 1-11 & Weeks 13-24The 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."
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 13
|
-2.96 units on a scale
Standard Error 0.203
|
-2.21 units on a scale
Standard Error 0.202
|
-2.87 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 23
|
-2.14 units on a scale
Standard Error 0.205
|
-2.12 units on a scale
Standard Error 0.204
|
-2.30 units on a scale
Standard Error 0.203
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 10
|
-3.31 units on a scale
Standard Error 0.202
|
-2.08 units on a scale
Standard Error 0.201
|
-3.07 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 11
|
-3.21 units on a scale
Standard Error 0.203
|
-2.13 units on a scale
Standard Error 0.202
|
-3.01 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 1
|
-1.9 units on a scale
Standard Error 0.202
|
-1.04 units on a scale
Standard Error 0.200
|
-2.13 units on a scale
Standard Error 0.201
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 2
|
-2.95 units on a scale
Standard Error 0.202
|
-1.61 units on a scale
Standard Error 0.201
|
-2.69 units on a scale
Standard Error 0.201
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 3
|
-3.20 units on a scale
Standard Error 0.202
|
-1.66 units on a scale
Standard Error 0.201
|
-2.93 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 4
|
-3.23 units on a scale
Standard Error 0.202
|
-1.84 units on a scale
Standard Error 0.200
|
-3.11 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 5
|
-3.34 units on a scale
Standard Error 0.202
|
-1.87 units on a scale
Standard Error 0.201
|
-3.11 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 6
|
-3.48 units on a scale
Standard Error 0.202
|
-1.95 units on a scale
Standard Error 0.201
|
-3.20 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 7
|
-3.48 units on a scale
Standard Error 0.202
|
-2.01 units on a scale
Standard Error 0.201
|
-3.03 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 14
|
-2.91 units on a scale
Standard Error 0.203
|
-2.18 units on a scale
Standard Error 0.202
|
-2.73 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 8
|
-3.48 units on a scale
Standard Error 0.202
|
-1.96 units on a scale
Standard Error 0.202
|
-3.04 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 9
|
-3.45 units on a scale
Standard Error 0.202
|
-2.06 units on a scale
Standard Error 0.202
|
-3.06 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 15
|
-2.84 units on a scale
Standard Error 0.204
|
-2.12 units on a scale
Standard Error 0.202
|
-2.75 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 16
|
-2.73 units on a scale
Standard Error 0.204
|
-2.22 units on a scale
Standard Error 0.203
|
-2.67 units on a scale
Standard Error 0.203
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 17
|
-2.66 units on a scale
Standard Error 0.204
|
-2.18 units on a scale
Standard Error 0.203
|
-2.57 units on a scale
Standard Error 0.203
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 18
|
-2.60 units on a scale
Standard Error 0.204
|
-2.13 units on a scale
Standard Error 0.203
|
-2.55 units on a scale
Standard Error .0203
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 19
|
-2.57 units on a scale
Standard Error 0.204
|
-2.19 units on a scale
Standard Error 0.203
|
-2.48 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 20
|
-2.44 units on a scale
Standard Error 0.204
|
-2.18 units on a scale
Standard Error 0.203
|
-2.46 units on a scale
Standard Error 0.202
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 21
|
-2.27 units on a scale
Standard Error 0.204
|
-2.16 units on a scale
Standard Error 0.203
|
-2.27 units on a scale
Standard Error 0.203
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 22
|
-2.18 units on a scale
Standard Error 0.205
|
-2.20 units on a scale
Standard Error 0.204
|
-2.29 units on a scale
Standard Error 0.203
|
|
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Week 24
|
-1.99 units on a scale
Standard Error 0.205
|
-2.16 units on a scale
Standard Error 0.203
|
-2.18 units on a scale
Standard Error 0.203
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24The 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.
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
Week 4
|
-1.10 units on a scale
Standard Error 0.068
|
-0.50 units on a scale
Standard Error 0.067
|
-0.87 units on a scale
Standard Error 0.067
|
|
Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
Week 8
|
-1.02 units on a scale
Standard Error 0.071
|
-0.48 units on a scale
Standard Error 0.070
|
-0.81 units on a scale
Standard Error 0.070
|
|
Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
Week 12
|
-0.88 units on a scale
Standard Error 0.071
|
-0.50 units on a scale
Standard Error 0.071
|
-0.70 units on a scale
Standard Error 0.070
|
|
Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
Week 16
|
-0.67 units on a scale
Standard Error 0.072
|
-0.54 units on a scale
Standard Error 0.071
|
-0.64 units on a scale
Standard Error 0.071
|
|
Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
Week 20
|
-0.61 units on a scale
Standard Error 0.069
|
-0.51 units on a scale
Standard Error 0.069
|
-0.60 units on a scale
Standard Error 0.068
|
|
Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
Week 24
|
-0.63 units on a scale
Standard Error 0.070
|
-0.49 units on a scale
Standard Error 0.070
|
-0.56 units on a scale
Standard Error 0.069
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24The 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.
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 12
|
-1.03 units on a scale
Standard Error 0.079
|
-0.59 units on a scale
Standard Error 0.078
|
-0.80 units on a scale
Standard Error 0.078
|
|
Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 8
|
-1.24 units on a scale
Standard Error 0.078
|
-0.54 units on a scale
Standard Error 0.077
|
-0.92 units on a scale
Standard Error 0.077
|
|
Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 4
|
-1.23 units on a scale
Standard Error 0.079
|
-0.51 units on a scale
Standard Error 0.077
|
-1.00 units on a scale
Standard Error 0.078
|
|
Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 16
|
-0.80 units on a scale
Standard Error 0.080
|
-0.64 units on a scale
Standard Error 0.080
|
-0.71 units on a scale
Standard Error 0.079
|
|
Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 20
|
-0.66 units on a scale
Standard Error 0.078
|
-0.64 units on a scale
Standard Error 0.078
|
-0.58 units on a scale
Standard Error 0.077
|
|
Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 24
|
-0.67 units on a scale
Standard Error 0.080
|
-0.58 units on a scale
Standard Error 0.079
|
-0.57 units on a scale
Standard Error 0.079
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24The 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.
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 20
|
-0.65 units on a scale
Standard Error .068
|
-0.56 units on a scale
Standard Error .068
|
-0.57 units on a scale
Standard Error .067
|
|
Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 24
|
-0.59 units on a scale
Standard Error .069
|
-0.51 units on a scale
Standard Error .069
|
-0.54 units on a scale
Standard Error .068
|
|
Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 4
|
-1.11 units on a scale
Standard Error .066
|
-0.51 units on a scale
Standard Error .065
|
-0.87 units on a scale
Standard Error .065
|
|
Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 8
|
-1.09 units on a scale
Standard Error .068
|
-0.53 units on a scale
Standard Error .068
|
-0.80 units on a scale
Standard Error .068
|
|
Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 12
|
-0.93 units on a scale
Standard Error .069
|
-0.56 units on a scale
Standard Error .068
|
-0.72 units on a scale
Standard Error .068
|
|
Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Week 16
|
-0.69 units on a scale
Standard Error .069
|
-0.59 units on a scale
Standard Error .069
|
-0.62 units on a scale
Standard Error .069
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 4, 8, 12, and 24The 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.
Outcome measures
| Measure |
FX006 32mg
n=136 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=144 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=134 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
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
Week 4
|
23.50 units on a scale
Standard Error 1.896
|
8.93 units on a scale
Standard Error 1.832
|
15.60 units on a scale
Standard Error 1.882
|
|
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
Week 8
|
23.30 units on a scale
Standard Error 1.907
|
10.70 units on a scale
Standard Error 1.856
|
18.02 units on a scale
Standard Error 1.891
|
|
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
Week 12
|
21.19 units on a scale
Standard Error 1.907
|
12.22 units on a scale
Standard Error 1.869
|
15.77 units on a scale
Standard Error 1.895
|
|
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
Week 24
|
11.95 units on a scale
Standard Error 1.923
|
10.25 units on a scale
Standard Error 1.878
|
11.44 units on a scale
Standard Error 1.906
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 1-24The 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."
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
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)
Week 1
|
66 Participants
|
42 Participants
|
81 Participants
|
|
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)
Week 2
|
99 Participants
|
63 Participants
|
96 Participants
|
|
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)
Week 3
|
109 Participants
|
61 Participants
|
101 Participants
|
|
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)
Week 4
|
107 Participants
|
64 Participants
|
108 Participants
|
|
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)
Week 5
|
106 Participants
|
69 Participants
|
109 Participants
|
|
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)
Week 6
|
113 Participants
|
73 Participants
|
111 Participants
|
|
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)
Week 7
|
112 Participants
|
75 Participants
|
112 Participants
|
|
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)
Week 8
|
109 Participants
|
74 Participants
|
107 Participants
|
|
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)
Week 9
|
107 Participants
|
79 Participants
|
109 Participants
|
|
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)
Week 10
|
107 Participants
|
78 Participants
|
109 Participants
|
|
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)
Week 11
|
107 Participants
|
78 Participants
|
105 Participants
|
|
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)
Week 12
|
103 Participants
|
80 Participants
|
104 Participants
|
|
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)
Week 13
|
97 Participants
|
81 Participants
|
106 Participants
|
|
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)
Week 14
|
95 Participants
|
80 Participants
|
100 Participants
|
|
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)
Week 15
|
88 Participants
|
79 Participants
|
97 Participants
|
|
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)
Week 16
|
91 Participants
|
81 Participants
|
97 Participants
|
|
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)
Week 17
|
84 Participants
|
82 Participants
|
86 Participants
|
|
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)
Week 18
|
81 Participants
|
75 Participants
|
93 Participants
|
|
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)
Week 19
|
86 Participants
|
78 Participants
|
88 Participants
|
|
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)
Week 20
|
84 Participants
|
79 Participants
|
87 Participants
|
|
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)
Week 21
|
82 Participants
|
76 Participants
|
83 Participants
|
|
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)
Week 22
|
79 Participants
|
74 Participants
|
78 Participants
|
|
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)
Week 23
|
77 Participants
|
79 Participants
|
84 Participants
|
|
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)
Week 24
|
70 Participants
|
74 Participants
|
74 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 1-24Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
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)
Week 15
|
73 Participants
|
55 Participants
|
70 Participants
|
|
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)
Week 16
|
71 Participants
|
59 Participants
|
70 Participants
|
|
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)
Week 17
|
69 Participants
|
59 Participants
|
67 Participants
|
|
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)
Week 18
|
66 Participants
|
52 Participants
|
66 Participants
|
|
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)
Week 19
|
64 Participants
|
54 Participants
|
67 Participants
|
|
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)
Week 1
|
39 Participants
|
21 Participants
|
57 Participants
|
|
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)
Week 2
|
73 Participants
|
37 Participants
|
67 Participants
|
|
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)
Week 3
|
81 Participants
|
40 Participants
|
77 Participants
|
|
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)
Week 4
|
86 Participants
|
47 Participants
|
80 Participants
|
|
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)
Week 5
|
85 Participants
|
51 Participants
|
80 Participants
|
|
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)
Week 6
|
92 Participants
|
51 Participants
|
84 Participants
|
|
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)
Week 7
|
97 Participants
|
49 Participants
|
85 Participants
|
|
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)
Week 8
|
97 Participants
|
53 Participants
|
82 Participants
|
|
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)
Week 9
|
91 Participants
|
55 Participants
|
83 Participants
|
|
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)
Week 10
|
87 Participants
|
57 Participants
|
84 Participants
|
|
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)
Week 11
|
83 Participants
|
60 Participants
|
80 Participants
|
|
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)
Week 12
|
80 Participants
|
56 Participants
|
75 Participants
|
|
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)
Week 13
|
79 Participants
|
57 Participants
|
77 Participants
|
|
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)
Week 14
|
76 Participants
|
54 Participants
|
72 Participants
|
|
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)
Week 20
|
60 Participants
|
54 Participants
|
62 Participants
|
|
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)
Week 21
|
56 Participants
|
54 Participants
|
61 Participants
|
|
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)
Week 22
|
56 Participants
|
52 Participants
|
57 Participants
|
|
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)
Week 23
|
51 Participants
|
54 Participants
|
63 Participants
|
|
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)
Week 24
|
47 Participants
|
49 Participants
|
56 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to >30% improvement (measured up to 30 days)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
Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
Time to Onset of Pain Relief
|
4 days
Interval 4.0 to 5.0
|
11 days
Interval 7.0 to 24.0
|
3 days
Interval 3.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 1-24Outcome measures
| Measure |
FX006 32mg
n=161 Participants
FX006: Single 5 mL IA injection
|
Placebo
n=162 Participants
Normal Saline: Single 5 mL IA injection.
|
TCA IR 40 mg
n=161 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 23
|
0.94 tablets (1 tablet = 500 mg)
Standard Error 0.143
|
1.20 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
0.97 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week1
|
1.01 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
1.31 tablets (1 tablet = 500 mg)
Standard Error 0.139
|
1.10 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 2
|
0.69 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
1.39 tablets (1 tablet = 500 mg)
Standard Error 0.139
|
1.00 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 3
|
0.69 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
1.35 tablets (1 tablet = 500 mg)
Standard Error 0.139
|
1.02 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 4
|
0.58 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
1.28 tablets (1 tablet = 500 mg)
Standard Error 0.139
|
0.90 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 5
|
0.60 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
1.21 tablets (1 tablet = 500 mg)
Standard Error 0.139
|
0.83 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 6
|
0.56 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
1.24 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
0.87 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 7
|
0.60 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
1.19 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
0.89 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 8
|
0.63 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
1.24 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
0.85 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 9
|
0.66 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
1.11 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
0.91 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 10
|
0.67 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
1.21 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
1.01 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 11
|
0.73 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
1.12 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
0.89 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 12
|
0.62 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
1.13 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
0.93 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 13
|
0.68 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
1.14 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
0.97 tablets (1 tablet = 500 mg)
Standard Error 0.140
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 14
|
0.67 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.18 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
0.98 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 15
|
0.67 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.25 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
0.90 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 16
|
0.71 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.15 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
0.93 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 17
|
0.82 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.17 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
0.95 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 18
|
0.87 tablets (1 tablet = 500 mg)
Standard Error 0.143
|
1.15 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.08 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 19
|
0.71 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.23 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
0.98 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 20
|
0.69 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.22 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
0.94 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 21
|
0.92 tablets (1 tablet = 500 mg)
Standard Error 0.143
|
1.23 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.02 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 22
|
0.98 tablets (1 tablet = 500 mg)
Standard Error 0.143
|
1.21 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
0.98 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
|
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Week 24
|
0.95 tablets (1 tablet = 500 mg)
Standard Error 0.144
|
1.18 tablets (1 tablet = 500 mg)
Standard Error 0.142
|
1.04 tablets (1 tablet = 500 mg)
Standard Error 0.141
|
Adverse Events
FX006 32mg
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
TCA IR 40 mg
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FX006 32mg
n=161 participants at risk
FX006: Single 5 mL IA injection
|
Placebo
n=162 participants at risk
Normal Saline: Single 5 mL IA injection
|
TCA IR 40 mg
n=161 participants at risk
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
Infections and infestations
Pneumonia:
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia:
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.62%
1/162 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Nervous system disorders
Seizure Tonic Clonic
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Cardiac disorders
Unstable Angina
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.62%
1/162 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.62%
1/162 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Nervous system disorders
Dizziness
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/161 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.00%
0/162 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
0.62%
1/161 • Number of events 1 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
Other adverse events
| Measure |
FX006 32mg
n=161 participants at risk
FX006: Single 5 mL IA injection
|
Placebo
n=162 participants at risk
Normal Saline: Single 5 mL IA injection
|
TCA IR 40 mg
n=161 participants at risk
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
23/161 • Number of events 23 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
12.3%
20/162 • Number of events 20 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
7.5%
12/161 • Number of events 12 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Vascular disorders
Headache
|
8.7%
14/161 • Number of events 14 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
8.0%
13/162 • Number of events 13 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
9.3%
15/161 • Number of events 15 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
9/161 • Number of events 9 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
5.6%
9/162 • Number of events 9 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
7.5%
12/161 • Number of events 12 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
5/161 • Number of events 5 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
4.3%
7/162 • Number of events 7 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
6.8%
11/161 • Number of events 11 • Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
|
Additional Information
Scott Kelley, VP of Medical Affairs
Flexion Therapeutics
Phone: 781-305-7142
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER