efficacy and tolerability of metamizol in patients with episodic moderate headache

Conditions: Migraine Disorders

Summary: the objective of the study was to evaluate the efficacy, safety and tolerability of a single peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid in 2 episodes of moderate tension headache.


Eligibility criteria:
inclusion criteria: * male and female patients between 18 and 65 years old * moderate episodic tension headache according to international headache society (i.h.s.) classification 2.1 (2.1.1 and 2.1.2) for at least one year * at least two episodes of tension headache per month in the last three months prior to enrolment into this trial * the episodes of tension headaches were usually treated by the patient successfully with a non-opioid-analgesic * first episodic headache occurred at an age under 50 years * written informed consent according to good clinical practice (gcp) and local regulations * the patient was able to fill in the patient's diary exclusion criteria: * the patient usually needs for successful treatment of tension headache "over the counter" (otc) analgesic in doses exceeding the doses tested here * the patient takes an otc-analgesic normally at the first signs of an episode of tension headache * the patient has more than 15 episodes of tension headache per month * female patients whose episodic tension headache is strongly correlated with the start of hormonal contraception * concomitant treatment with (non-) prescriptional analgesics * pre- (less than 4 weeks prior to inclusion in this trial) and/or concomitant treatment with an antidepressive and/or antipsychotic drug * pre- (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug such as nsaids (non-steroidal anti inflammatory drugs), propanolol, metroprolol, flunarizin, cyclandelate, valproic-acid, serotonergic antagonists, ergotamine, dihydroergotamines and benzodiazepines that may influence the headache symptomatology * use of benzodiazepines in the previous 24 hours to the administration of the study drug. occasional use of benzodiazepines - up to 3 per week - is allowed * use of any drug with analgesic properties in the previous 24 hours to the administration of the study drug * concomitant treatment with any drug containing asa and/or metamizol * concomitant treatment with anticoagulants such as heparin or coumarin-derivatives * alcohol and drug abuse according to dsm-iv (diagnostic and statistical manual of mental disorders ) * female patients in child-bearing age not using adequate means of birth control * pregnancy and/or lactation * gastrointestinal ulcers * liver and/or renal disease * bronchial asthma * relevant allergy or known hypersensitivity to the investigational drugs, its excipients and/or to other nsaids * participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial * patients with active gastroesophageal flux disease (amendment number 1) * concomitant treatment with analgesics or any other drug that may have influenced the headache symptomatology - including metamizol or asa -, was referred to its use during the headache episodes under evaluation. as long as appropriate wash-out periods were respected, analgesics were allowed in between the episodes of tension headache (th) and their use as a rescue medication did not lead to the exclusion of the patient (amendment number 2)