Trial Outcomes & Findings for Study of FX006 in Patients With Osteoarthritis of the Knee (NCT NCT01487161)
NCT ID: NCT01487161
Last Updated: 2024-01-24
Results Overview
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."
COMPLETED
PHASE2
229 participants
8 weeks
2024-01-24
Participant Flow
This study took place at 22 centers across the United States, Canada and Australia. Enrollment took approximately 7 months.
Subjects were screened within 21 days of being randomized
Participant milestones
| Measure |
FX006 10 mg
58 subjects received FX006 10 mg as a single 3 mL IA injection.
|
FX006 40 mg
59 subjects received FX006 40 mg as a single 3 mL IA injection.
|
FX006 60 mg
60 subjects received FX006 60 mg as a single 3 mL IA injection.
|
TCA IR (40 mg)
51 subjects received TCA IR 40 mg as a single 1 mL IA injection.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
60
|
52
|
|
Overall Study
COMPLETED
|
56
|
57
|
59
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
FX006 10 mg
58 subjects received FX006 10 mg as a single 3 mL IA injection.
|
FX006 40 mg
59 subjects received FX006 40 mg as a single 3 mL IA injection.
|
FX006 60 mg
60 subjects received FX006 60 mg as a single 3 mL IA injection.
|
TCA IR (40 mg)
51 subjects received TCA IR 40 mg as a single 1 mL IA injection.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
2
|
|
Overall Study
missing data
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of FX006 in Patients With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
FX006 10 mg
n=58 Participants
Single 3 mL IA injection
|
FX006 40 mg
n=59 Participants
Single 3 mL IA injection
|
FX006 60 mg
n=60 Participants
Single 3 mL IA injection
|
TCA IR (40 mg)
n=51 Participants
Single 1 mL IA injection
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.5 years
n=99 Participants
|
60.9 years
n=107 Participants
|
61.9 years
n=206 Participants
|
61.6 years
n=7 Participants
|
61.5 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
120 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
108 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.
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."
Outcome measures
| Measure |
FX006 60 mg
n=56 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=43 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
|
-3.9 units on a scale
Standard Error 0.28
|
-3.4 units on a scale
Standard Error 0.31
|
—
|
—
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.
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."
Outcome measures
| Measure |
FX006 60 mg
n=56 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=45 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
|
-3.6 units on a scale
Standard Error 0.28
|
-3.3 units on a scale
Standard Error 0.31
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.
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."
Outcome measures
| Measure |
FX006 60 mg
n=53 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=41 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
|
-3.2 units on a scale
Standard Error 0.30
|
-3.3 units on a scale
Standard Error 0.33
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 8, 10 and 12Population: All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.
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."
Outcome measures
| Measure |
FX006 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=51 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg
8 Weeks
|
-3.9 units on a scale
Standard Error 0.28
|
-4.3 units on a scale
Standard Error 0.28
|
-3.4 units on a scale
Standard Error 0.31
|
—
|
|
Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg
10 Weeks
|
-3.8 units on a scale
Standard Error 0.29
|
-4.1 units on a scale
Standard Error 0.29
|
-3.3 units on a scale
Standard Error 0.31
|
—
|
|
Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg
12 Weeks
|
-3.6 units on a scale
Standard Error 0.30
|
-3.7 units on a scale
Standard Error 0.30
|
-3.3 units on a scale
Standard Error 0.33
|
—
|
SECONDARY outcome
Timeframe: Weeks 1-7 and Week 9 and 11Population: All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.
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."
Outcome measures
| Measure |
FX006 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=60 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=51 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 1
|
-2.7 units on a scale
Standard Error 0.24
|
-3.0 units on a scale
Standard Error 0.24
|
-3.0 units on a scale
Standard Error 0.24
|
-3.1 units on a scale
Standard Error 0.26
|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 2
|
-3.6 units on a scale
Standard Error 0.27
|
-3.9 units on a scale
Standard Error 0.27
|
-3.8 units on a scale
Standard Error 0.27
|
-3.5 units on a scale
Standard Error 0.29
|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 3
|
-3.7 units on a scale
Standard Error 0.27
|
-4.1 units on a scale
Standard Error 0.27
|
-4.2 units on a scale
Standard Error 0.27
|
-3.5 units on a scale
Standard Error 0.29
|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 4
|
-3.8 units on a scale
Standard Error 0.26
|
-4.3 units on a scale
Standard Error 0.26
|
-4.2 units on a scale
Standard Error 0.26
|
-3.7 units on a scale
Standard Error 0.28
|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 5
|
-3.9 units on a scale
Standard Error 0.28
|
-4.3 units on a scale
Standard Error 0.27
|
-4.2 units on a scale
Standard Error 0.27
|
-3.5 units on a scale
Standard Error 0.30
|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 6
|
-4.0 units on a scale
Standard Error 0.28
|
-4.3 units on a scale
Standard Error 0.28
|
-4.2 units on a scale
Standard Error 0.28
|
-3.4 units on a scale
Standard Error 0.30
|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 7
|
-3.9 units on a scale
Standard Error 0.28
|
-4.4 units on a scale
Standard Error 0.28
|
-3.9 units on a scale
Standard Error 0.27
|
-3.3 units on a scale
Standard Error 0.30
|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 9
|
-3.8 units on a scale
Standard Error 0.30
|
-4.2 units on a scale
Standard Error 0.30
|
-3.7 units on a scale
Standard Error 0.29
|
-3.3 units on a scale
Standard Error 0.32
|
|
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
Week 11
|
-3.7 units on a scale
Standard Error 0.30
|
-3.9 units on a scale
Standard Error 0.30
|
-3.2 units on a scale
Standard Error 0.29
|
-3.4 units on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: 8 weeksThe 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 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=60 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=47 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
WOMAC A (Pain Subscale) Change From Baseline at Week 8
|
-1.23 units on a scale
Standard Error 0.099
|
-1.33 units on a scale
Standard Error 0.098
|
-1.16 units on a scale
Standard Error 0.097
|
-0.96 units on a scale
Standard Error 0.108
|
SECONDARY outcome
Timeframe: 8 weeksThe 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 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=60 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=47 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8
|
-1.2 units on a scale
Standard Error 0.12
|
-1.2 units on a scale
Standard Error 0.12
|
-1.1 units on a scale
Standard Error 0.11
|
-0.8 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 8 weeksThe 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 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=60 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=47 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
WOMAC B (Stiffness Subscale) Change From Baseline at Week 8
|
-1.37 units on a scale
Standard Error 0.113
|
-1.49 units on a scale
Standard Error 0.112
|
-1.24 units on a scale
Standard Error 0.111
|
-0.99 units on a scale
Standard Error 0.124
|
SECONDARY outcome
Timeframe: 8 weeksThe 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 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=58 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=60 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=47 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
WOMAC C (Function Subscale) Change From Baseline at Week 8
|
-1.22 units on a scale
Standard Error 0.096
|
-1.31 units on a scale
Standard Error 0.096
|
-1.13 units on a scale
Standard Error 0.095
|
-0.94 units on a scale
Standard Error 0.106
|
SECONDARY outcome
Timeframe: 8 weeksOutcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function.
Outcome measures
| Measure |
FX006 60 mg
n=57 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=46 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Percent of Responders According to OMERACT-OARSI Criteria at Week 8
|
52 Participants
|
53 Participants
|
47 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 8 weeksThe 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 60 mg
n=55 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=55 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=56 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=43 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
|
35 Participants
|
40 Participants
|
34 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 8 weeksThe 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 60 mg
n=55 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=55 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=56 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=43 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
|
42 Participants
|
47 Participants
|
45 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 8 weeksThe 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 60 mg
n=55 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=55 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=56 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=43 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
|
47 Participants
|
49 Participants
|
48 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Week 8The 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.
Outcome measures
| Measure |
FX006 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=60 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=48 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Patient Global Impression of Change Scores at Week 8
|
1.9 units on a scale
Standard Error 0.16
|
1.8 units on a scale
Standard Error 0.16
|
2.4 units on a scale
Standard Error 0.16
|
2.5 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: 8 weeksThe Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's 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.
Outcome measures
| Measure |
FX006 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=60 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=48 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Clinical Global Impression of Change Scores at Week 8
|
1.9 units on a scale
Standard Deviation 0.16
|
1.8 units on a scale
Standard Deviation 0.16
|
2.5 units on a scale
Standard Deviation 0.16
|
2.6 units on a scale
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
FX006 60 mg
n=58 Participants
FX006: Single 3 mL IA injection
|
TCA IR 40 mg
n=59 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=60 Participants
TCA IR: Single 1 mL IA injection
|
TCA IR 40 mg
n=48 Participants
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
|
1.0 tablets (1tablet= 500 mg)
Standard Error 0.22
|
1.0 tablets (1tablet= 500 mg)
Standard Error 0.22
|
1.1 tablets (1tablet= 500 mg)
Standard Error 0.22
|
1.2 tablets (1tablet= 500 mg)
Standard Error 0.24
|
Adverse Events
FX006 10 mg
FX006 40 mg
FX006 60 mg
TCA IR (40 mg)
Serious adverse events
| Measure |
FX006 10 mg
n=58 participants at risk
FX006: Single 3 mL IA injection
|
FX006 40 mg
n=59 participants at risk
FX006: Single 3 mL IA injection
|
FX006 60 mg
n=60 participants at risk
FX006: Single 3 mL IA injection
|
TCA IR (40 mg)
n=51 participants at risk
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/58 • Adverse events were collected from post injection on Day 1 through Day 85
|
1.7%
1/59 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/60 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/51 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/58 • Adverse events were collected from post injection on Day 1 through Day 85
|
1.7%
1/59 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/60 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/51 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/58 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/59 • Adverse events were collected from post injection on Day 1 through Day 85
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/51 • Adverse events were collected from post injection on Day 1 through Day 85
|
Other adverse events
| Measure |
FX006 10 mg
n=58 participants at risk
FX006: Single 3 mL IA injection
|
FX006 40 mg
n=59 participants at risk
FX006: Single 3 mL IA injection
|
FX006 60 mg
n=60 participants at risk
FX006: Single 3 mL IA injection
|
TCA IR (40 mg)
n=51 participants at risk
TCA IR: Single 1 mL IA injection
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngits
|
3.4%
2/58 • Number of events 2 • Adverse events were collected from post injection on Day 1 through Day 85
|
3.4%
2/59 • Number of events 2 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/60 • Adverse events were collected from post injection on Day 1 through Day 85
|
5.9%
3/51 • Number of events 3 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/59 • Adverse events were collected from post injection on Day 1 through Day 85
|
11.7%
7/60 • Number of events 7 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/51 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Investigations
Alanine Aminotransferase Increased
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/59 • Adverse events were collected from post injection on Day 1 through Day 85
|
5.0%
3/60 • Number of events 3 • Adverse events were collected from post injection on Day 1 through Day 85
|
2.0%
1/51 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Investigations
Blood Glucose Increased
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
1.7%
1/59 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
5.0%
3/60 • Number of events 3 • Adverse events were collected from post injection on Day 1 through Day 85
|
2.0%
1/51 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Investigations
Neutrophil Count Increased
|
0.00%
0/58 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/59 • Adverse events were collected from post injection on Day 1 through Day 85
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
5.9%
3/51 • Number of events 3 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Investigations
White Blood Cell Count Inreased
|
0.00%
0/58 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/59 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/60 • Adverse events were collected from post injection on Day 1 through Day 85
|
7.8%
4/51 • Number of events 4 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
8.6%
5/58 • Number of events 5 • Adverse events were collected from post injection on Day 1 through Day 85
|
13.6%
8/59 • Number of events 8 • Adverse events were collected from post injection on Day 1 through Day 85
|
6.7%
4/60 • Number of events 4 • Adverse events were collected from post injection on Day 1 through Day 85
|
3.9%
2/51 • Number of events 2 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
3.4%
2/58 • Number of events 2 • Adverse events were collected from post injection on Day 1 through Day 85
|
0.00%
0/59 • Adverse events were collected from post injection on Day 1 through Day 85
|
3.3%
2/60 • Number of events 2 • Adverse events were collected from post injection on Day 1 through Day 85
|
5.9%
3/51 • Number of events 3 • Adverse events were collected from post injection on Day 1 through Day 85
|
|
Nervous system disorders
Headache
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from post injection on Day 1 through Day 85
|
8.5%
5/59 • Number of events 5 • Adverse events were collected from post injection on Day 1 through Day 85
|
3.3%
2/60 • Number of events 2 • Adverse events were collected from post injection on Day 1 through Day 85
|
9.8%
5/51 • Number of events 5 • Adverse events were collected from post injection on Day 1 through Day 85
|
Additional Information
Scott Kelley, VP of Medical Affairs
Flexion Therapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place