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NCT01115673 · ClinicalTrials.gov registry record · Phase 3
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
A Phase 3 study of Pain, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
- Completed
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
- 1
- Study location
NCT01115673: Completed Phase 3 study of Pain, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
NCT01115673 is a Phase 3 study of Pain that has completed, run by McNeil Consumer Healthcare Division of McNEIL-PPC. The registered enrollment target is 540 participants, above the 303-participant average among 374 other Pain trials with a reported enrollment target (78% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01115673, a Phase 3 study of Pain, has completed, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
Primary Outcome
Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed ti
Conditions Studied
Interventions
- DRUG Acetaminophen
- DRUG Placebo Control
Study Locations (1)
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
What the finished NCT01115673 record still lists
NCT01115673 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, above the 303-participant average among 374 other Pain trials with a reported enrollment target (78% higher).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Acetaminophen is the first listed.
NCT01115673 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01115673 about?
NCT01115673 is a clinical study titled "To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery". The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
What is the current status of trial NCT01115673?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2010-06. Estimated completion is 2011-01.
What conditions does trial NCT01115673 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT01115673?
The interventions under investigation include: Acetaminophen (DRUG), Placebo Control (DRUG).
Who is sponsoring clinical trial NCT01115673?
This trial is sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01115673 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 NCT01115673's enrollment target sits among peer trials
540 27th of 374 higher than 348 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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