Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Pfizer.
NCT02912650 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 568 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; a
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 |
What the finished NCT02912650 record still lists
NCT02912650 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02912650 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02912650's enrollment target sits among peer trials
568 666th of 2000 higher than 1,334 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
- NCT05472441 · 568 participants · NA
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
- NCT05000645 · 570 participants · NA
Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
- NCT06239844 · 570 participants · NA
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
- NCT06701903 · 570 participants · Phase 2
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
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