Conditions: Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 365
Healthy volunteers: yes

Brief 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).

Detailed description:

Arms:
arm 1: Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered arm 2: Two ibuprofen caplets plus two placebo caplets to be administered arm 3: Four placebo caplets to be administered

Interventions: intervention 1: Paracetamol and Caffeine intervention 2: Ibuprofen intervention 3: Placebo
Intervention descriptions: intervention 1: Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine intervention 2: Caplets containing 200 mg of ibuprofen intervention 3: Matching placebo caplets

Protocol document: