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NCT02912650 · ClinicalTrials.gov registry record · Phase 3
A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 568
- Enrollment target
NCT02912650 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 568 participants.
The verdict
NCT02912650, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 568 participants
- Enrollment target
Study Summary
This is a randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. Subjects will provide self-ratings of pain severity and pain relief at various time points using categorical and numerical scales. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will complete a categorical Global Evaluation of the study medication. A review of any reported adverse events will also be completed.
Interventions
- DRUG Placebo
- DRUG Acetaminophen 650 mg
- DRUG Ibuprofen 250 mg / Acetaminophen 500 mg
- DRUG Ibuprofen 250 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02912650
The ClinicalTrials.gov registry entry for NCT02912650 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 568 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 4 interventions - of which Placebo is the first listed.
NCT02912650 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02912650 about?
NCT02912650 is a clinical study titled "A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain". This is a randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg alone, acetaminophen 650 m...
What is the current status of trial NCT02912650?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 568 participants. The study started on 2015-09. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02912650?
The interventions under investigation include: Placebo (DRUG), Acetaminophen 650 mg (DRUG), Ibuprofen 250 mg / Acetaminophen 500 mg (DRUG), Ibuprofen 250 mg (DRUG).
Who is sponsoring clinical trial NCT02912650?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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