NCT01929031

Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 562 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pain, Postoperative
• Tooth Diseases

Interventions

Type	Name	Description
DRUG	ibuprofen + caffeine	FDC tablet
DRUG	ibuprofen	tablet.
DRUG	ibuprofen	tablet
DRUG	caffeine	tablet
DRUG	ibuprofen + caffeine	Fixed Dose Combination (FDC) tablet
DRUG	placebo	tablet
DRUG	placebo	tablet
DRUG	caffeine	tablet
DRUG	ibuprofen	tablet
DRUG	ibuprofen + caffeine	FDC tablet

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-08-27
• Last updated: 2016-11-16
• Results posted: 2016-11-16

Locations

1 site across 1 country: United States