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NCT03793010 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
A Phase 3 study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
NCT03793010: Clinical Trial Phase 3 study, sponsored by Pacira Pharmaceuticals.
NCT03793010 is a Phase 3 study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 70 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03793010, a Phase 3 study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
Study Summary
This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, 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.
Primary Outcome
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 questions with a range from 0 (no pain) to 10 (extreme pain).
Interventions
- DRUG Normal saline
- DRUG FX006
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2019-08-07 |
| Phase | Phase 3 |
Why NCT03793010 stopped before completion
NCT03793010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT03793010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03793010 about?
NCT03793010 is a clinical study titled "Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis". This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one...
What is the current status of trial NCT03793010?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2018-12-12. Estimated completion is 2019-08-07.
What interventions are being tested in trial NCT03793010?
The interventions under investigation include: Normal saline (DRUG), FX006 (DRUG).
Who is sponsoring clinical trial NCT03793010?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03793010's enrollment target sits among peer trials
70 1785th of 2000 higher than 208 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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