Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT02181920
Status:
TERMINATED
Last Update Posted:
2014-07-18
First Post:
2014-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metamizol for the Treatment of Neoplastic Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004177', 'term': 'Dipyrone'}, {'id': 'D004008', 'term': 'Diclofenac'}], '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': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2014-07-02', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in morphine requirement', 'timeFrame': 'Baseline, 9 days'}]}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Study to evaluate the efficacy of metamizole in reducing morphine requirements in patients with moderate to severe chronic cancer pain in comparison to administration of placebo or diclofenac.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients with neoplastic chronic pain requiring morphine treatment\n\nExclusion Criteria:\n\n* Karnofsky index less than 30%'}, 'identificationModule': {'nctId': 'NCT02181920', 'briefTitle': 'Metamizol for the Treatment of Neoplastic Chronic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Analgesic Effect of a New Metamizol Oral Pharmaceutical Form for the Treatment of the Neoplastic Chronic Pain: Randomized, Double-blind Crossover Clinical Trial Between Metamizol, Diclofenac and Placebo', 'orgStudyIdInfo': {'id': '1093.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metamizole - Diclofenac', 'description': 'metamizole followed by diclofenac', 'interventionNames': ['Drug: Metamizole', 'Drug: Diclofenac', 'Drug: Diclofenac placebo', 'Drug: Metamizole placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Diclofenac - Metamizole', 'description': 'diclofenac followed by metamizole', 'interventionNames': ['Drug: Metamizole', 'Drug: Diclofenac', 'Drug: Diclofenac placebo', 'Drug: Metamizole placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Metamizole - Placebo', 'description': 'metamizole followed by placebo', 'interventionNames': ['Drug: Metamizole', 'Drug: Diclofenac placebo', 'Drug: Metamizole placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - Metamizole', 'description': 'placebo followed by metamizole', 'interventionNames': ['Drug: Metamizole', 'Drug: Diclofenac placebo', 'Drug: Metamizole placebo']}], 'interventions': [{'name': 'Metamizole', 'type': 'DRUG', 'armGroupLabels': ['Diclofenac - Metamizole', 'Metamizole - Diclofenac', 'Metamizole - Placebo', 'Placebo - Metamizole']}, {'name': 'Diclofenac', 'type': 'DRUG', 'armGroupLabels': ['Diclofenac - Metamizole', 'Metamizole - Diclofenac']}, {'name': 'Diclofenac placebo', 'type': 'DRUG', 'armGroupLabels': ['Diclofenac - Metamizole', 'Metamizole - Diclofenac', 'Metamizole - Placebo', 'Placebo - Metamizole']}, {'name': 'Metamizole placebo', 'type': 'DRUG', 'armGroupLabels': ['Diclofenac - Metamizole', 'Metamizole - Diclofenac', 'Metamizole - Placebo', 'Placebo - Metamizole']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}