Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT02642861
Status:
UNKNOWN
Last Update Posted:
2018-01-03
First Post:
2015-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004704', 'term': 'cyclobenzaprine'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-30', 'studyFirstSubmitDate': '2015-12-25', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of muscle cramps', 'timeFrame': '3 months', 'description': 'The number of muscle cramps'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': '\\- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.', 'detailedDescription': 'Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.\n\n\\- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver cirrhosis and has frequent muscle cramps\n\nExclusion Criteria:\n\n* Allergy to cyclobenzaprine\n* Encephalopathy.\n* Receiving antidepressant drugs'}, 'identificationModule': {'nctId': 'NCT02642861', 'briefTitle': 'Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'Muscle cramps treatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclobenzaprine', 'description': 'Cyclobenzaprine administration for 2 weeks', 'interventionNames': ['Drug: Cyclobenzaprine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLacebo', 'description': 'Calcium carbonate for 2 weeks', 'interventionNames': ['Drug: Calcium Carbonate']}], 'interventions': [{'name': 'Cyclobenzaprine', 'type': 'DRUG', 'otherNames': ['cyclosed'], 'description': 'cyclobenzaprine administration for 2 weeks', 'armGroupLabels': ['Cyclobenzaprine']}, {'name': 'Calcium Carbonate', 'type': 'DRUG', 'otherNames': ['Calcitron'], 'description': 'Calcium carbonate for 2 weeks', 'armGroupLabels': ['PLacebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta university - faculty of medicine', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief M. Abd-Elsalam, Consultant', 'role': 'CONTACT', 'email': 'sherif_tropical@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Sherief M. Abd-Elsalam, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'liver diseases dept.- Tanta university hospital'}, {'name': 'Walaa A. Elkhalawany, Consultant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'liver diseases dept.- Tanta university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant liver and GIT diseases- Tanta university hospital', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}