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NCT00985439 · ClinicalTrials.gov registry record · Phase 2
Study of Diclofenac Capsules to Treat Dental Pain
A Phase 2 study, sponsored by Iroko Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
NCT00985439: Completed Phase 2 study, sponsored by Iroko Pharmaceuticals.
NCT00985439 is a Phase 2 study that has completed, run by Iroko Pharmaceuticals. The registered enrollment target is 202 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00985439, a Phase 2 study, has completed, sponsored by Iroko Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Diclofenac 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 0-12 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 Celecoxib 400 mg
- DRUG Diclofenac Test (lower dose)
- DRUG Diclofenac Test (upper dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2009-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00985439 record still lists
NCT00985439 is an interventional study that assigns participants to a tested intervention. The registered 202 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 (52% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00985439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00985439 about?
NCT00985439 is a clinical study titled "Study of Diclofenac Capsules to Treat Dental Pain". The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.
What is the current status of trial NCT00985439?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2009-09. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00985439?
The interventions under investigation include: Placebo (DRUG), Celecoxib 400 mg (DRUG), Diclofenac Test (lower dose) (DRUG), Diclofenac Test (upper dose) (DRUG).
Who is sponsoring clinical trial NCT00985439?
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 NCT00985439's enrollment target sits among peer trials
202 301st of 2000 higher than 1,699 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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