Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183220
• Other study ID #: 1093.16
• Status: Completed
• Phase: Phase 3
• First received: July 4, 2014
• Last updated: July 4, 2014
• Start date: October 1998

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Metamizol

• Acetylsalicylic acid (ASA)

• Metamizol placebo

• ASA placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

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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