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NCT01510912 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
A Phase 3 study, sponsored by Iroko Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 602
- Enrollment target
NCT01510912: Completed Phase 3 study, sponsored by Iroko Pharmaceuticals.
NCT01510912 is a Phase 3 study that has completed, run by Iroko Pharmaceuticals. The registered enrollment target is 602 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01510912, a Phase 3 study, has completed, sponsored by Iroko Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 602 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of Diclofenac \[Test\] Capsules for the treatment of osteoarthritis pain of the knee or hip.
Primary Outcome
The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.
Interventions
- DRUG Diclofenac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01510912 record still lists
NCT01510912 is an interventional study that assigns participants to a tested intervention. The registered 602 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 (22% lower).
The record links to 0 conditions, and to 1 intervention - of which Diclofenac is the first listed.
NCT01510912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01510912 about?
NCT01510912 is a clinical study titled "Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain". The purpose of this study is to evaluate the safety of Diclofenac \[Test\] Capsules for the treatment of osteoarthritis pain of the knee or hip.
What is the current status of trial NCT01510912?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 602 participants. The study started on 2012-01. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01510912?
The interventions under investigation include: Diclofenac (DRUG).
Who is sponsoring clinical trial NCT01510912?
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 NCT01510912's enrollment target sits among peer trials
602 607th of 2000 higher than 1,393 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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