Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-01 @ 7:45 PM
Study NCT ID:
NCT03865004
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056844', 'term': 'Renal Colic'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118296', 'term': 'dexketoprofen trometamol'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain reductions in VAS scores during the 60th and 90th minutes', 'timeFrame': '60 minutes'}], 'secondaryOutcomes': [{'measure': 'Need for rescue analgesic', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Colic']}, 'descriptionModule': {'briefSummary': 'This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Renal colic patients -\n\nExclusion Criteria: Not renal colic patients\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03865004', 'briefTitle': 'Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Paracetamol Plus Morphine in ED', 'orgStudyIdInfo': {'id': 'firatbektas'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Paracetamol+Morphine', 'Drug: Dexketoprofen plus Morphine', 'Drug: Placebo plus Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol', 'interventionNames': ['Drug: Paracetamol+Morphine', 'Drug: Dexketoprofen plus Morphine', 'Drug: Placebo plus Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexketoprofene', 'interventionNames': ['Drug: Paracetamol+Morphine', 'Drug: Dexketoprofen plus Morphine', 'Drug: Placebo plus Morphine']}], 'interventions': [{'name': 'Paracetamol+Morphine', 'type': 'DRUG', 'otherNames': ['Parol'], 'description': '1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously', 'armGroupLabels': ['Dexketoprofene', 'Paracetamol', 'Placebo']}, {'name': 'Dexketoprofen plus Morphine', 'type': 'DRUG', 'otherNames': ['Arveles'], 'description': 'Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously', 'armGroupLabels': ['Dexketoprofene', 'Paracetamol', 'Placebo']}, {'name': 'Placebo plus Morphine', 'type': 'DRUG', 'otherNames': ['SF'], 'description': '100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously', 'armGroupLabels': ['Dexketoprofene', 'Paracetamol', 'Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}