Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02761980 · ClinicalTrials.gov registry record · Phase 3
A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 290
- Enrollment target
NCT02761980: Completed Phase 3 study, sponsored by Pfizer.
NCT02761980 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 290 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02761980, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 290 participants
- Enrollment target
Study Summary
This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.
Primary Outcome
WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5,
Interventions
- DRUG Placebo
- DRUG Ibuprofen 250 mg / Acetaminophen 500 mg
- DRUG Ibuprofen 250 mg
- DRUG Acetaminophen 500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2016-12-06 |
| Est. Completion | 2017-12-06 |
| Phase | Phase 3 |
What the finished NCT02761980 record still lists
NCT02761980 is an interventional study that assigns participants to a tested intervention. The registered 290 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 (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02761980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02761980 about?
NCT02761980 is a clinical study titled "A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers". This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acet...
What is the current status of trial NCT02761980?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2016-12-06. Estimated completion is 2017-12-06.
What interventions are being tested in trial NCT02761980?
The interventions under investigation include: Placebo (DRUG), Ibuprofen 250 mg / Acetaminophen 500 mg (DRUG), Ibuprofen 250 mg (DRUG), Acetaminophen 500 mg (DRUG).
Who is sponsoring clinical trial NCT02761980?
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 NCT02761980's enrollment target sits among peer trials
290 1171st of 2000 higher than 828 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
- NCT00775476 · 290 participants · Phase 2
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
- NCT01874197 · 290 participants · NA
Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic
- NCT04331353 · 290 participants · NA
The Allergen Reduction and Child Health Study (ARCHS)
- NCT04649008 · 290 participants · Early Phase 1
Localizing Epileptic Networks Using MRI and iEEG
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI