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NCT01266161 · ClinicalTrials.gov registry record · Phase 3
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
A Phase 3 study of Pain, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 2
- Study locations
NCT01266161: Completed Phase 3 study of Pain, sponsored by Pfizer.
NCT01266161 is a Phase 3 study of Pain that has completed, run by Pfizer. The registered enrollment target is 106 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (65% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01266161, a Phase 3 study of Pain, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 2
- Study locations
Study Summary
The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.
Primary Outcome
SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \[=\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ibuprofen 600 mg ER
Study Locations (2)
Texas
- Central Texas Oral Surgery Associates - Austin
- Premier Research - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2010-11-22 |
| Est. Completion | 2011-03-31 |
| Phase | Phase 3 |
What the finished NCT01266161 record still lists
NCT01266161 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01266161 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01266161 about?
NCT01266161 is a clinical study titled "Multiple Dose Dental Pain Study Of Ibuprofen Extended Release". The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.
What is the current status of trial NCT01266161?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2010-11-22. Estimated completion is 2011-03-31.
What conditions does trial NCT01266161 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT01266161?
The interventions under investigation include: Placebo (DRUG), Ibuprofen 600 mg ER (DRUG).
Who is sponsoring clinical trial NCT01266161?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01266161 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01266161's enrollment target sits among peer trials
106 157th of 374 higher than 217 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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
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