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NCT01229228 · ClinicalTrials.gov registry record · Phase 2
Study of Naproxen Capsules to Treat Dental Pain
A Phase 2 study, sponsored by Iroko Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 254
- Enrollment target
NCT01229228: Completed Phase 2 study, sponsored by Iroko Pharmaceuticals.
NCT01229228 is a Phase 2 study that has completed, run by Iroko Pharmaceuticals. The registered enrollment target is 254 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01229228, a Phase 2 study, has completed, sponsored by Iroko Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 254 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.
Primary Outcome
Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.
Interventions
- DRUG Placebo
- DRUG Naproxen Test
- DRUG Naprosyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT01229228 record still lists
NCT01229228 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01229228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01229228 about?
NCT01229228 is a clinical study titled "Study of Naproxen Capsules to Treat Dental Pain". The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.
What is the current status of trial NCT01229228?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2010-10. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01229228?
The interventions under investigation include: Placebo (DRUG), Naproxen Test (DRUG), Naprosyn (DRUG).
Who is sponsoring clinical trial NCT01229228?
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 NCT01229228's enrollment target sits among peer trials
254 219th of 2000 higher than 1,781 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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