At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 106 enrolled
Drug / intervention
Ibuprofen 600 mg ER +1 moredrug
Likely dose
Ibuprofen 600 mg ERfrom 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 Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet
In Brief
A Phase 3 clinical trial evaluating Ibuprofen 600 mg ER and Placebo for Pain. Completed, enrolled 106 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedDec 2010
Primary CompletionMar 2011
TodayJul 2026
First PostedDec 24, 2010
Enrollment StartNov 22, 2010
Primary CompletionMar 31, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.5 years ago
Interventions
Ibuprofen 600 mg ERdrug
One 600 mg caplet dosed at 0, 12, 24 and 36 hours
Placebodrug
One placebo caplet dosed at times 0, 12, 24 and 36 hours