Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03793010|
Recruitment Status : Active, not recruiting
First Posted : January 4, 2019
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip||Drug: FX006 Drug: Normal saline||Phase 3|
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 440 patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.
FX006 or saline placebo will be administered as a single IA injection with a 12-week follow-up period in the double-blind phase.
Patients eligible for the second injection in the open-label phase at Week 12 will receive an open-label injection of FX006 at Week 12 and return for follow-up visits at Weeks 16, 20, and 24. These patients will complete the study at Week 24.
Patients who are not clinically indicated for a second injection at Week 12 will return to the clinic at Weeks 16, 20, and 24 and will receive an open-label injection of FX006 at the first evaluation where the patient has been determined to meet all criteria. Patients will then return for follow-up visits every 4 weeks for 12 weeks post second injection and will complete the study 12 weeks post second injection (e.g., Week 24, 28, 32, or 36 depending on when the patient receives the open-label injection).
Patients who are not eligible for a second injection after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 visit and complete the End of Study (EOS) assessments.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-blind, Placebo-controlled, Parallel-group|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis|
|Actual Study Start Date :||December 12, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Single Intra-articular injection
Placebo Comparator: Normal Saline
Drug: Normal saline
Single Intra-articular injection
- Change in WOMAC A (pain) score at Week 12 [ Time Frame: Baseline to Week 12 ]The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five subscales with a range from 0 (no pain) to 10 (extreme pain).
- Change in WOMAC C (function) score at Week 12 [ Time Frame: Baseline to Week 12 ]Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen subscales with a range from 0 (no difficulty) to 10 (extreme difficulty).
- PGIC score at Week 12 [ Time Frame: Baseline at Week 12 ]PGIC (Patient Global Impression of Change) at week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793010
Show 32 Study Locations
|Study Director:||Scott Kelley, MD||Flexion Therapeutics, Inc.|