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Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache

NCT01842633 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2017-09-01

Study results available
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Summary

The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).

Conditions

Interventions

DRUG

Paracetamol and Caffeine

Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine

DRUG

Ibuprofen

Caplets containing 200 mg of ibuprofen

OTHER

Placebo

Matching placebo caplets

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT01842633 on ClinicalTrials.gov