- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183220
Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache
July 4, 2014 updated by: Boehringer Ingelheim
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
417
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Metamizol high & Placebo
|
|
Experimental: Metamizol low & Placebo
|
|
Active Comparator: Acetylsalicylic acid & Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS)
Time Frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain intensity difference (PID) on a VAS
Time Frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
Maximum pain intensity difference (MAXPID) on a VAS
Time Frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
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
Time Frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
Time to 50% pain intensity reduction on a VAS
Time Frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS)
Time Frame: 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
30 minutes, 1, 2, 3, and 4 hours after drug intake
|
Total pain relief (TOTPAR) on a VRS
Time Frame: 30 minutes, 1, 2, 3, and 4 hours after drug intake
|
30 minutes, 1, 2, 3, and 4 hours after drug intake
|
Number of patients using rescue medication
Time Frame: 2, 3, and 4 hours after drug intake
|
2, 3, and 4 hours after drug intake
|
Global efficacy assessment on a VRS by the patient and investigator
Time Frame: 4 hours after drug intake
|
4 hours after drug intake
|
Number of patients with adverse events
Time Frame: up to 2 months
|
up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1998
Primary Completion (Actual)
July 1, 1999
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Headache
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
- Dipyrone
Other Study ID Numbers
- 1093.16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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