At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 403 enrolled
Drug / intervention
Acetaminophen ER +1 moredrug
Likely dose
Acetaminophen ER 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.·interventional·Posted Oct 10, 2013·Updated Jul 10, 2015
In Brief
A Phase 2 clinical trial evaluating Acetaminophen ER and Placebo for Dental Pain. Completed, enrolled 403 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedOct 2013
Primary CompletionApr 2014
TodayJul 2026
First PostedOct 10, 2013
Enrollment StartOct 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.7 years ago
Interventions
Acetaminophen ERdrug
Single dose (2 tablets) Acetaminophen ER 750 mg
Placebodrug
Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo