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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-01

Study Completion Date

2015-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Paracetamol/ Caffeine Caplets

Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered

Group Type EXPERIMENTAL

Paracetamol and Caffeine

Intervention Type DRUG

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

Ibuprofen Caplets

Two ibuprofen caplets plus two placebo caplets to be administered

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Caplets containing 200 mg of ibuprofen

Placebo Caplets

Four placebo caplets to be administered

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo caplets

Interventions

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Paracetamol and Caffeine

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

Intervention Type DRUG

Ibuprofen

Caplets containing 200 mg of ibuprofen

Intervention Type DRUG

Placebo

Matching placebo caplets

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants in good general health, and with diagnosis of ETTH with following conditions:

1. number of days with the condition is historically greater than or equal to two per month;
2. severity of headaches is historically at least moderate;
3. duration of headaches is historically more than or equal to 4 hours, if untreated.

Exclusion Criteria

* Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
* Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.
* Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes