Evaluation of tolerability and analgesic activity of paracetamol 1000 mg+caffeine 130 mg in the treatment of tension-type headache. Randomized, double blind, double-dummy, cross-over study vs. naproxene 550 mg and placebo.

INTERVENTION: Trade Name: Anilidi Product Name: Anilides Pharmaceutical Form: Effervescent granules INN or Proposed INN: paracetamol+caffeine Current Sponsor code: 044(2A)SC04030 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000‐ Trade Name: Naproxene Product Name: Naproxene Pharmaceutical Form: Coated tablet INN or Proposed INN: Naproxen Other descriptive name: 044(2A)SC04030 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 550‐ CONDITION: Evaluation of tolerability and analgesic activity in the treatment of tension‐type headache ; Level: PT Classification code 10043269 PRIMARY OUTCOME: Main Objective: Primary end point(s): Secondary Objective: INCLUSION CRITERIA: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range