Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00964431 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
A Phase 2 study, sponsored by Iroko Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 203
- Enrollment target
NCT00964431: Completed Phase 2 study, sponsored by Iroko Pharmaceuticals.
NCT00964431 is a Phase 2 study that has completed, run by Iroko Pharmaceuticals. The registered enrollment target is 203 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00964431, a Phase 2 study, has completed, sponsored by Iroko Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 203 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.
Primary Outcome
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 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 32.
Interventions
- DRUG Placebo
- DRUG Celecoxib 400 mg
- DRUG Indomethacin Test (lower dose)
- DRUG Indomethacin Test (upper dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2009-08 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00964431 record still lists
NCT00964431 is an interventional study that assigns participants to a tested intervention. The registered 203 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 (53% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00964431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00964431 about?
NCT00964431 is a clinical study titled "Phase 2 Study of Indomethacin Capsules to Treat Dental Pain". The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.
What is the current status of trial NCT00964431?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2009-08. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00964431?
The interventions under investigation include: Placebo (DRUG), Celecoxib 400 mg (DRUG), Indomethacin Test (lower dose) (DRUG), Indomethacin Test (upper dose) (DRUG).
Who is sponsoring clinical trial NCT00964431?
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 NCT00964431's enrollment target sits among peer trials
203 301st of 2000 higher than 1,700 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05652686 · 203 participants · Phase 1
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
- NCT06063122 · 203 participants · NA
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
- NCT07031245 · 203 participants · NA
Evidence-Based Quality Improvement to Reduce VA Primary Care Burnout
- NCT03481010 · 204 participants · NA
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia