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NCT01216163 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
A Phase 3 study of Pain, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
- 1
- Study location
NCT01216163: Completed Phase 3 study of Pain, sponsored by Pfizer.
NCT01216163 is a Phase 3 study of Pain that has completed, run by Pfizer. The registered enrollment target is 218 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01216163, a Phase 3 study of Pain, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
Primary Outcome
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -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=moderate to 3=severe). Total score range for PID: -1 (worst) to 3
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acetaminophen
- DRUG Novel Ibuprofen
Study Locations (1)
Utah
- Pfizer Investigational Site - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
What the finished NCT01216163 record still lists
NCT01216163 is an interventional study that assigns participants to a tested intervention. The registered 218 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 (28% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01216163 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01216163 about?
NCT01216163 is a clinical study titled "Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain". This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
What is the current status of trial NCT01216163?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2010-10. Estimated completion is 2011-01.
What conditions does trial NCT01216163 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT01216163?
The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Novel Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT01216163?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01216163 being conducted?
This trial has 1 study location across Utah. 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 NCT01216163's enrollment target sits among peer trials
218 82nd of 374 higher than 293 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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