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NCT01461369 · ClinicalTrials.gov registry record · Phase 3
Study of Diclofenac Capsules to Treat Osteoarthritis Pain
A Phase 3 study, sponsored by Iroko Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 305
- Enrollment target
NCT01461369: Completed Phase 3 study, sponsored by Iroko Pharmaceuticals.
NCT01461369 is a Phase 3 study that has completed, run by Iroko Pharmaceuticals. The registered enrollment target is 305 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01461369, a Phase 3 study, has completed, sponsored by Iroko Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 305 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.
Primary Outcome
The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extr
Interventions
- DRUG Placebo
- DRUG Diclofenac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-10 |
| Phase | Phase 3 |
What the finished NCT01461369 record still lists
NCT01461369 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01461369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01461369 about?
NCT01461369 is a clinical study titled "Study of Diclofenac Capsules to Treat Osteoarthritis Pain". The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.
What is the current status of trial NCT01461369?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2011-10. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01461369?
The interventions under investigation include: Placebo (DRUG), Diclofenac (DRUG).
Who is sponsoring clinical trial NCT01461369?
This trial is sponsored by Iroko Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01461369's enrollment target sits among peer trials
305 1117th of 2000 higher than 884 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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