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NCT01626118 · ClinicalTrials.gov registry record · Phase 3
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
A Phase 3 study of Other Acute Postoperative Pain, sponsored by Iroko Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 373
- Enrollment target
- 4
- Study locations
NCT01626118: Completed Phase 3 study of Other Acute Postoperative Pain, sponsored by Iroko Pharmaceuticals.
NCT01626118 is a Phase 3 study of Other Acute Postoperative Pain that has completed, run by Iroko Pharmaceuticals. The registered enrollment target is 373 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01626118, a Phase 3 study of Other Acute Postoperative Pain, has completed, sponsored by Iroko Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 373 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours. The VAS summed pain intensi
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Indomethacin
Study Locations (4)
Arizona
- Premier Research Group Limited - Phoenix
Maryland
- Chesapeake Research Group, LLC - Pasadena
Texas
- Premier Research Group Limited - Austin
Utah
- Premier Research Group Limited - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT01626118 record still lists
NCT01626118 is an interventional study that assigns participants to a tested intervention. The registered 373 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 (52% lower).
The record links to 1 condition, with Other Acute Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01626118 reports a single indexed study location in Arizona, Maryland, Texas.
Frequently Asked Questions
What is clinical trial NCT01626118 about?
NCT01626118 is a clinical study titled "Study of Indomethacin Capsules to Treat Pain Following Bunionectomy". The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
What is the current status of trial NCT01626118?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 373 participants. The study started on 2012-05. Estimated completion is 2012-08.
What conditions does trial NCT01626118 study?
This clinical trial studies the following conditions: Other Acute Postoperative Pain.
What interventions are being tested in trial NCT01626118?
The interventions under investigation include: Placebo (DRUG), Indomethacin (DRUG).
Who is sponsoring clinical trial NCT01626118?
This trial is sponsored by Iroko Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01626118 being conducted?
This trial has 4 study locations across Arizona, Maryland, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01626118's enrollment target sits among peer trials
373 991st of 2000 higher than 1,010 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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