At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 408 enrolled
Drug / intervention
Maxigesic 325 +3 moredrug
Likely dose
Maxigesic 325 325 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.
Maxigesic 325 Acute Dental Pain Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 Versus Acetaminophen, Ibuprofen and Placebo in Participants With Acute Dental Pain
In Brief
A Phase 3 clinical trial evaluating Maxigesic 325, Acetaminophen, and 2 other interventions for Dental Pain. Completed, enrolled 408 participants across 4 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Pain
CountriesNew Zealand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartApr 2013
Primary CompletionDec 2014
Study CompletionJan 2015
TodayJul 2026
First PostedAug 22, 2011
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.9 years ago
Interventions
Maxigesic 325drug
Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
Acetaminophendrug
Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
Ibuprofendrug
Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
Placebodrug
placebo, three tablets four times a day, with food for 48 hours