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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 3

Conditions: Pain

Treatments: Drug: Paracetamol and Caffeine; Drug: Ibuprofen; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01842633

202172

RH01649 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 365 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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365 participants in 3 patient groups, including a placebo group

Paracetamol/ Caffeine Caplets

Experimental group

Description:

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

Treatment:

Drug: Paracetamol and Caffeine

Ibuprofen Caplets

Active Comparator group

Description:

Two ibuprofen caplets plus two placebo caplets to be administered

Treatment:

Drug: Ibuprofen

Placebo Caplets

Placebo Comparator group

Description:

Four placebo caplets to be administered

Treatment:

Other: Placebo