Trial Outcomes & Findings for Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip (NCT NCT04065074)
NCT ID: NCT04065074
Last Updated: 2024-01-24
Results Overview
Successful study drug administration, defined as Injector reporting complete study drug administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Day 1
Results posted on
2024-01-24
Participant Flow
Participant milestones
| Measure |
FX006 32 mg
Single intra-articular (IA) injection of FX006 32 mg
FX006 32 mg: Extended-release 32 mg FX006 IA injection
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
FX006 32 mg
Single intra-articular (IA) injection of FX006 32 mg
FX006 32 mg: Extended-release 32 mg FX006 IA injection
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Non-Compliance after injection
|
1
|
Baseline Characteristics
Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip
Baseline characteristics by cohort
| Measure |
FX006 32 mg
n=16 Participants
Single intra-articular (IA) injection of FX006 32 mg
FX006 32 mg: Extended-release 32 mg FX006 IA injection
|
|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 7.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.56 kg/m^2
STANDARD_DEVIATION 6.785 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Successful study drug administration, defined as Injector reporting complete study drug administration.
Outcome measures
| Measure |
FX006 32 mg
n=16 Participants
Single intra-articular (IA) injection of FX006 32 mg
FX006 32 mg: Extended-release 32 mg FX006 IA injection
|
|---|---|
|
Number of Patients With Successful Study Drug Administrations
|
12 Participants
|
Adverse Events
FX006 32 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FX006 32 mg
n=16 participants at risk
Single intra-articular (IA) injection of FX006 32 mg
FX006 32 mg: Extended-release 32 mg FX006 IA injection
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Subchondrial Insufficiency Fracture
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected from signing of informed consent to Last Visit.
|
Other adverse events
Adverse event data not reported
Additional Information
David Golod, Vice President, Clinical Operations
Flexion Therapeutics, Inc.
Phone: (781) 305-7572
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60