Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-13 @ 11:43 PM
Study NCT ID:
NCT02423395
Status:
RECRUITING
Last Update Posted:
2019-06-07
First Post:
2015-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D009120', 'term': 'Muscle Cramp'}], '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'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009966', 'term': 'Orphenadrine'}, {'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2015-04-21', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of muscle cramps', 'timeFrame': '3 months', 'description': 'questionnaire'}], 'secondaryOutcomes': [{'measure': 'Quality of life of these patients', 'timeFrame': '3 months', 'description': 'questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Liver Cirrhosis', 'Muscle Cramps']}, 'referencesModule': {'references': [{'pmid': '31834056', 'type': 'DERIVED', 'citation': 'Abd-Elsalam S, Ebrahim S, Soliman S, Alkhalawany W, Elfert A, Hawash N, Elkadeem M, Badawi R. Orphenadrine in treatment of muscle cramps in cirrhotic patients: a randomized study. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):1042-1045. doi: 10.1097/MEG.0000000000001622.'}]}, 'descriptionModule': {'briefSummary': 'Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. \\[3,4\\]', 'detailedDescription': 'Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes \\[1\\].\n\nAlthough 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 \\[2\\].\n\nOrphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. \\[3,4\\] Orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, It is mostly excreted through the kidneys.\\[5\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhosis\n* Muscle cramps( ≥3 cramps per week )\n\nExclusion Criteria:\n\n* • Allergy to orphenadrine\n\n * Renal impairment\n * Pregnant and lactating women\n * Peripheral vascular disease\n * Peripheral neuropathy\n * Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement'}, 'identificationModule': {'nctId': 'NCT02423395', 'briefTitle': "Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis", 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': "Randomized Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis", 'orgStudyIdInfo': {'id': 'muscle cramps in cirrhotics'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orphenadrine(Norflex)', 'description': '50 patients will be treated with orphenadrine 100 mg twice daily for 1 month', 'interventionNames': ['Drug: orphenadrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '50 patients will be given placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'orphenadrine', 'type': 'DRUG', 'otherNames': ['Norflex'], 'description': 'Orphenadrine in muscle cramps in cirrhotic patients', 'armGroupLabels': ['Orphenadrine(Norflex)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['calcium'], 'description': 'calcium in muscle cramps in cirrhotic patients', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-Elsalam', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '00201000040794'}], 'facility': 'Tanta university hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief M Abd-Elsalam, lecturer', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '01000058842', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Asem A Elfert, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TUH'}, {'name': 'Samah Mosaad, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'TUH'}, {'name': 'Lobna Aboaly, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'TUH'}, {'name': 'Walaa ElKhalawany, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'TUH'}, {'name': 'Sherief Abd-Elsalam, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TUH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Study director', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}