Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache
Phase 3
Completed
- Conditions
- Migraine Disorders
- Interventions
- Registration Number
- NCT02183220
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 417
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo ASA placebo - Metamizol low & Placebo Metamizol - Metamizol high & Placebo Metamizol placebo - Metamizol low & Placebo Metamizol placebo - Acetylsalicylic acid & Placebo Acetylsalicylic acid (ASA) - Placebo Metamizol placebo - Acetylsalicylic acid & Placebo ASA placebo - Metamizol high & Placebo Metamizol -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS) 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 Total pain relief (TOTPAR) on a VRS 30 minutes, 1, 2, 3, and 4 hours after drug intake Number of patients with adverse events up to 2 months Global efficacy assessment on a VRS by the patient and investigator 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 Maximum pain intensity difference (MAXPID) 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