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Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache

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ClinicalTrials.gov Identifier: NCT02183220
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Metamizol Drug: Acetylsalicylic acid (ASA) Drug: Metamizol placebo Drug: ASA placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : October 1998
Actual Primary Completion Date : July 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Dipyrone

Arm Intervention/treatment
Experimental: Metamizol high & Placebo Drug: Metamizol
Drug: Metamizol placebo
Experimental: Metamizol low & Placebo Drug: Metamizol
Drug: Metamizol placebo
Active Comparator: Acetylsalicylic acid & Placebo Drug: Acetylsalicylic acid (ASA)
Drug: ASA placebo
Placebo Comparator: Placebo Drug: Metamizol placebo
Drug: ASA placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pain intensity difference (PID) on a VAS [ Time Frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake ]
  2. Maximum pain intensity difference (MAXPID) on a VAS [ Time Frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake ]
  3. 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 ]
  4. Time to 50% pain intensity reduction on a VAS [ Time Frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake ]
  5. Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS) [ Time Frame: 30 minutes, 1, 2, 3, and 4 hours after drug intake ]
  6. Total pain relief (TOTPAR) on a VRS [ Time Frame: 30 minutes, 1, 2, 3, and 4 hours after drug intake ]
  7. Number of patients using rescue medication [ Time Frame: 2, 3, and 4 hours after drug intake ]
  8. Global efficacy assessment on a VRS by the patient and investigator [ Time Frame: 4 hours after drug intake ]
  9. Number of patients with adverse events [ Time Frame: up to 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183220    
Other Study ID Numbers: 1093.16
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Dipyrone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics