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NCT01462435 · ClinicalTrials.gov registry record · Phase 3
Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
A Phase 3 study, sponsored by Iroko Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 428
- Enrollment target
NCT01462435: Completed Phase 3 study, sponsored by Iroko Pharmaceuticals.
NCT01462435 is a Phase 3 study that has completed, run by Iroko Pharmaceuticals. The registered enrollment target is 428 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01462435, a Phase 3 study, has completed, sponsored by Iroko Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 428 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 bunionectomy pain.
Primary Outcome
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at
Interventions
- DRUG Placebo
- DRUG Celecoxib
- DRUG Diclofenac Test (lower dose)
- DRUG Diclofenac Test (upper dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT01462435 record still lists
NCT01462435 is an interventional study that assigns participants to a tested intervention. The registered 428 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 (45% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01462435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01462435 about?
NCT01462435 is a clinical study titled "Study of Diclofenac Capsules to Treat Pain Following Bunionectomy". The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.
What is the current status of trial NCT01462435?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 428 participants. The study started on 2011-10. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01462435?
The interventions under investigation include: Placebo (DRUG), Celecoxib (DRUG), Diclofenac Test (lower dose) (DRUG), Diclofenac Test (upper dose) (DRUG).
Who is sponsoring clinical trial NCT01462435?
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 NCT01462435's enrollment target sits among peer trials
428 878th of 2000 higher than 1,121 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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