Migraine Disorders Clinical Trial
Official title:
A Randomised, Double Blind, Placebo- and Active-controlled Parallel Group Study Investigating the Efficacy and Tolerability of Metamizol 0.5 g and 1.0 g in Patients With Episodic Moderate Tension Headache.
NCT number | NCT02183220 |
Other study ID # | 1093.16 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | July 4, 2014 |
Last updated | July 4, 2014 |
Start date | October 1998 |
Verified date | July 2014 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ministry of HealthSpain: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 417 |
Est. completion date | |
Est. primary completion date | July 1999 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Pain intensity difference (PID) on a VAS | before and 30 minutes, 1, 2, 3, and 4 hours after drug intake | No | |
Secondary | Maximum pain intensity difference (MAXPID) on a VAS | before and 30 minutes, 1, 2, 3, and 4 hours after drug intake | No | |
Secondary | 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 | No | |
Secondary | Time to 50% pain intensity reduction on a VAS | before and 30 minutes, 1, 2, 3, and 4 hours after drug intake | No | |
Secondary | Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS) | 30 minutes, 1, 2, 3, and 4 hours after drug intake | No | |
Secondary | Total pain relief (TOTPAR) on a VRS | 30 minutes, 1, 2, 3, and 4 hours after drug intake | No | |
Secondary | Number of patients using rescue medication | 2, 3, and 4 hours after drug intake | No | |
Secondary | Global efficacy assessment on a VRS by the patient and investigator | 4 hours after drug intake | No | |
Secondary | Number of patients with adverse events | up to 2 months | No |
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