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NCT00913627 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
NCT00913627: Completed Phase 2 study, sponsored by Pfizer.
NCT00913627 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00913627, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, \[roller compaction\] and \[wet granulation\] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.
Primary Outcome
Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity).
Interventions
- DRUG Placebo
- DRUG ibuprofen
- DRUG naproxen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2009-05-07 |
| Est. Completion | 2009-08-05 |
| Phase | Phase 2 |
What the finished NCT00913627 record still lists
NCT00913627 is an interventional study that assigns participants to a tested intervention. The registered 196 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 (47% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00913627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00913627 about?
NCT00913627 is a clinical study titled "Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain". The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two form...
What is the current status of trial NCT00913627?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2009-05-07. Estimated completion is 2009-08-05.
What interventions are being tested in trial NCT00913627?
The interventions under investigation include: Placebo (DRUG), ibuprofen (DRUG), naproxen (DRUG).
Who is sponsoring clinical trial NCT00913627?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00913627's enrollment target sits among peer trials
196 349th of 2000 higher than 1,651 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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