Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-04-14 @ 8:10 AM
Study NCT ID:
NCT02183220
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004177', 'term': 'Dipyrone'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D000632', 'term': 'Aminopyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 417}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS)', 'timeFrame': 'before and 30 minutes, 1, 2, 3, and 4 hours after drug intake'}], 'secondaryOutcomes': [{'measure': 'Pain intensity difference (PID) on a VAS', 'timeFrame': 'before and 30 minutes, 1, 2, 3, and 4 hours after drug intake'}, {'measure': 'Maximum pain intensity difference (MAXPID) on a VAS', 'timeFrame': 'before and 30 minutes, 1, 2, 3, and 4 hours after drug intake'}, {'measure': 'Number of patients with at least a 50% pain reduction on a VAS', 'timeFrame': 'before and 30 minutes, 1, 2, 3, and 4 hours after drug intake'}, {'measure': 'Time to 50% pain intensity reduction on a VAS', 'timeFrame': 'before and 30 minutes, 1, 2, 3, and 4 hours after drug intake'}, {'measure': 'Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS)', 'timeFrame': '30 minutes, 1, 2, 3, and 4 hours after drug intake'}, {'measure': 'Total pain relief (TOTPAR) on a VRS', 'timeFrame': '30 minutes, 1, 2, 3, and 4 hours after drug intake'}, {'measure': 'Number of patients using rescue medication', 'timeFrame': '2, 3, and 4 hours after drug intake'}, {'measure': 'Global efficacy assessment on a VRS by the patient and investigator', 'timeFrame': '4 hours after drug intake'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 2 months'}]}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients between 18 and 65 years old\n* 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\n* At least two episodes of tension headache per month in the last three months prior to enrolment into this trial\n* The episodes of tension headaches were usually treated by the patient successfully with a non-opioid-analgesic\n* First episodic headache occurred at an age under 50 years\n* Written informed consent according to Good Clinical Practice (GCP) and local regulations\n* The patient was able to fill in the Patient\'s Diary\n\nExclusion Criteria:\n\n* The patient usually needs for successful treatment of tension headache "Over The Counter" (OTC) analgesic in doses exceeding the doses tested here\n* The patient takes an OTC-analgesic normally at the first signs of an episode of tension headache\n* The patient has more than 15 episodes of tension headache per month\n* Female patients whose episodic tension headache is strongly correlated with the start of hormonal contraception\n* Concomitant treatment with (non-) prescriptional analgesics\n* Pre- (less than 4 weeks prior to inclusion in this trial) and/or concomitant treatment with an antidepressive and/or antipsychotic drug\n* 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\n* 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\n* Use of any drug with analgesic properties in the previous 24 hours to the administration of the study drug\n* Concomitant treatment with any drug containing ASA and/or metamizol\n* Concomitant treatment with anticoagulants such as heparin or coumarin-derivatives\n* Alcohol and drug abuse according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders )\n* Female patients in child-bearing age not using adequate means of birth control\n* Pregnancy and/or lactation\n* Gastrointestinal ulcers\n* Liver and/or renal disease\n* Bronchial asthma\n* Relevant allergy or known hypersensitivity to the investigational drugs, its excipients and/or to other NSAIDs\n* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial\n* Patients with active gastroesophageal flux disease (Amendment number 1)\n* 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)'}, 'identificationModule': {'nctId': 'NCT02183220', 'briefTitle': 'Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '1093.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metamizol high & Placebo', 'interventionNames': ['Drug: Metamizol', 'Drug: Metamizol placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Metamizol low & Placebo', 'interventionNames': ['Drug: Metamizol', 'Drug: Metamizol placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetylsalicylic acid & Placebo', 'interventionNames': ['Drug: Acetylsalicylic acid (ASA)', 'Drug: ASA placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Metamizol placebo', 'Drug: ASA placebo']}], 'interventions': [{'name': 'Metamizol', 'type': 'DRUG', 'armGroupLabels': ['Metamizol high & Placebo', 'Metamizol low & Placebo']}, {'name': 'Acetylsalicylic acid (ASA)', 'type': 'DRUG', 'armGroupLabels': ['Acetylsalicylic acid & Placebo']}, {'name': 'Metamizol placebo', 'type': 'DRUG', 'armGroupLabels': ['Metamizol high & Placebo', 'Metamizol low & Placebo', 'Placebo']}, {'name': 'ASA placebo', 'type': 'DRUG', 'armGroupLabels': ['Acetylsalicylic acid & Placebo', 'Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}