Migraine Disorders
Conditions
Brief 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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS) | before and 30 minutes, 1, 2, 3, and 4 hours after drug intake |
Secondary
| Measure | Time frame |
|---|---|
| Maximum pain intensity difference (MAXPID) on a VAS | before and 30 minutes, 1, 2, 3, and 4 hours after drug intake |
| Number of patients with at least a 50% pain reduction on a VAS | before and 30 minutes, 1, 2, 3, and 4 hours after drug intake |
| Time to 50% pain intensity reduction on a VAS | before and 30 minutes, 1, 2, 3, and 4 hours after drug intake |
| Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS) | 30 minutes, 1, 2, 3, and 4 hours after drug intake |
| Pain intensity difference (PID) on a VAS | before and 30 minutes, 1, 2, 3, and 4 hours after drug intake |
| Number of patients using rescue medication | 2, 3, and 4 hours after drug intake |
| Global efficacy assessment on a VRS by the patient and investigator | 4 hours after drug intake |
| Number of patients with adverse events | up to 2 months |
| Total pain relief (TOTPAR) on a VRS | 30 minutes, 1, 2, 3, and 4 hours after drug intake |
Outcome results
None listed