At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-centre, Double-blind, Randomised, Two-stage, Parallel-group Study to Assess the Efficacy and Safety of the Fixed Dose Combination of Ibuprofen 400 mg and Caffeine 100 mg Versus Ibuprofen 400 mg, Caffeine 100 mg and Placebo in Patients With Postoperative Dental Pain
In Brief
A Phase 3 clinical trial evaluating ibuprofen + caffeine, ibuprofen, and 2 other interventions for Pain, Postoperative and Tooth Diseases. Completed, enrolled 562 participants across 1 site.
Detailed Summary
The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medication (study stage 1). A secondary objective is to evaluate efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day post-surgical period (study stage 2).
Study Details
Timeline
Interventions
FDC tablet
tablet.
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Fixed Dose Combination (FDC) tablet
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FDC tablet