At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 374 enrolled
Drug / intervention
Ibuprofen/Caffeine +2 moredrug
Likely dose
Not stated in 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 PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF A NOVEL FIXED-DOSE COMBINATION OF IBUPROFEN 400 MG WITH CAFFEINE 100 MG TO IBUPROFEN 400 MG AND TO PLACEBO IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN IN OTHERWISE HEALTHY SUBJECTS
In Brief
A Phase 3 clinical trial evaluating Ibuprofen/Caffeine, Ibuprofen, and 1 other intervention for Pain. Completed, enrolled 374 participants across 1 site.
Detailed Summary
An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartOct 2017
Primary CompletionApr 2018
TodayJul 2026
First PostedAug 11, 2016
Enrollment StartOct 24, 2017
Primary CompletionApr 6, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.9 years ago
Interventions
Ibuprofen/Caffeinedrug
Ibuprofen/Caffeine fixed-dose combination
Ibuprofendrug
Ibuprofen capsule
Placebodrug
Placebo treatment