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Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain

NCT01929031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2016-11-16

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929031 on ClinicalTrials.gov