Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache

NCT02183220 | Completed Phase 3

• 1 other identifier: 1093.16
• Study Type: interventional
• Target: 417
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

Study Arms (4)

Metamizol high & Placebo

EXPERIMENTAL

Drug: Metamizol; Drug: Metamizol placebo

Metamizol low & Placebo

EXPERIMENTAL

Drug: Metamizol; Drug: Metamizol placebo

Acetylsalicylic acid & Placebo

ACTIVE COMPARATOR

Drug: Acetylsalicylic acid (ASA); Drug: ASA placebo

Placebo

PLACEBO COMPARATOR

Drug: Metamizol placebo; Drug: ASA placebo

Interventions

Metamizol DRUG

Metamizol high & Placebo; Metamizol low & Placebo

Acetylsalicylic acid (ASA) DRUG

Acetylsalicylic acid & Placebo

Metamizol placebo DRUG

Metamizol high & Placebo; Metamizol low & Placebo; Placebo

ASA placebo DRUG

Acetylsalicylic acid & Placebo; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

Dipyrone; Aspirin

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: October 1, 1998
• Primary Completion: July 1, 1999
• Last Updated: July 8, 2014

Record last verified: 2014-07