Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01362491 · ClinicalTrials.gov registry record · Phase 3
Ibuprofen Sodium Tension Headache Study
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
NCT01362491: Completed Phase 3 study, sponsored by Pfizer.
NCT01362491 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 226 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362491, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
Study Summary
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache
Primary Outcome
SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(wors
Interventions
- DRUG Placebo
- DRUG Ibuprofen Sodium
- DRUG Standard Ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT01362491 record still lists
NCT01362491 is an interventional study that assigns participants to a tested intervention. The registered 226 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 (71% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01362491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01362491 about?
NCT01362491 is a clinical study titled "Ibuprofen Sodium Tension Headache Study". This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache
What is the current status of trial NCT01362491?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2011-06. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01362491?
The interventions under investigation include: Placebo (DRUG), Ibuprofen Sodium (DRUG), Standard Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT01362491?
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 NCT01362491's enrollment target sits among peer trials
226 1310th of 2000 higher than 690 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
- NCT04419272 · 226 participants · Phase 4
Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
- NCT05449002 · 226 participants · NA
Digital Single Session Intervention for Youth Mental Health
- NCT05488054 · 226 participants · NA
Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery
- NCT05924477 · 226 participants · NA
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
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