CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 562 enrolled
Drug / intervention
ibuprofen + caffeine +9 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.

Search/NCT01929031
NCT01929031Phase 3Completed

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

Boehringer Ingelheim·interventional·Posted Aug 27, 2013·Updated Nov 16, 2016

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 27, 2013
Enrollment StartAug 1, 2013
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.8 years ago

Interventions

ibuprofen + caffeinedrug

FDC tablet

ibuprofendrug

tablet.

ibuprofendrug

tablet

caffeinedrug

tablet

ibuprofen + caffeinedrug

Fixed Dose Combination (FDC) tablet

placebodrug

tablet

placebodrug

tablet

caffeinedrug

tablet

ibuprofendrug

tablet

ibuprofen + caffeinedrug

FDC tablet