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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 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 196 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00913627
The ClinicalTrials.gov registry entry for NCT00913627 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00913627 reports 0 study locations.
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.
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