Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01947920
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2013-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D008133', 'term': 'Long QT Syndrome'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-15', 'studyFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in vital signs and other parameters as a measure of safety and tolerability of tramadol', 'timeFrame': 'Baseline, Days 1 through 4', 'description': 'Changes in clinical laboratory results, vital signs, psycopharmacologic status (Richmond Agitation-Sedation Scale (RASS), and physical examination.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in time-matched electrocardiogram (ECG) measurements', 'timeFrame': 'Baseline, Day 1, Day 3 and Day 4', 'description': 'ECG will detect abnormal changes from baseline in cardiac depolarization/repolarization.'}, {'measure': 'Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite', 'timeFrame': 'Baseline, up to 72 hours after the 1st dose', 'description': 'Determination of concentrations of tramadol and M1 metabolite pharmacokinetic parameters in venous plasma.'}, {'measure': 'Incidence and type of adverse events', 'timeFrame': 'Baseline, till the end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy', 'Pain', 'Tramadol hydrochloride', 'Tramadol HCl', 'Analgesic', 'QT prolongation', 'RWJ-26898-002'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).', 'detailedDescription': "This is a randomized (study drug assigned by chance), sequential-cohort (time lagged), double-blind (neither the participant or the study doctor will know the name of the assigned treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of 3 treatment groups), single-center, Phase 1 study of multiple ascending doses of tramadol HCl in healthy adult volunteers. Thirty participants (15 men and 15 women) will be sequentially assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). Participants in each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol HCl or placebo, in the ratio of 4:1. The study includes a screening phase and a double-blind treatment phase. The treatment phase will consist of 3 treatment periods separated by a 5-day safety review period before the next ascending dose of study drug is administered to the next group. Participants in each group will be confined to the study center for a total of 5 days, the total duration of each subject's participation will be up to 33 days, including the screening phase. The total duration of the study (completion of all 3 treatment cohorts) will be up-to-approximately 2 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index between 18 and 30 kg/m², inclusive\n* body weight not less than 50 kg\n* have a normal electroencephalogram under basic and stimulated conditions\n* have a 12-lead ECG that is consistent with normal cardiac conduction and function\n* have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration\n\nExclusion Criteria:\n\n* any personal or family history of epileptic seizures or convulsions\n* have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection\n* have suffered from loss of consciousness of unknown origin\n* drowning or sudden infant death syndrome in a first degree relative'}, 'identificationModule': {'nctId': 'NCT01947920', 'briefTitle': 'A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Scientific Affairs, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Ascending Doses of Tramadol Hydrochloride in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'CR102458'}, 'secondaryIdInfos': [{'id': 'TRAMPAI1002', 'type': 'OTHER', 'domain': 'Janssen Scientific Affairs, LLC'}, {'id': 'V01-TRAA-501', 'type': 'OTHER', 'domain': 'Valeant Pharmaceuticals International Inc'}, {'id': '2013-01-00', 'type': 'OTHER', 'domain': 'Cipher Pharmaceuticals Inc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Tramadol HCl 200 mg daily or placebo', 'description': 'Participants will receive one capsule of Tramadol hydrochloride (HCl) every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered.', 'interventionNames': ['Drug: Tramadol HCl, 50 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2: Tramadol HCl 400 mg daily or placebo', 'description': 'Participants will recieve two capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered.', 'interventionNames': ['Drug: Tramadol HCl, 50 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3: Tramadol HCl 600 mg daily or placebo', 'description': 'Participants will receive three capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered.', 'interventionNames': ['Drug: Tramadol HCl, 50 mg', 'Drug: Placebo']}], 'interventions': [{'name': 'Tramadol HCl, 50 mg', 'type': 'DRUG', 'description': '50-mg overencapsulated tablet for oral administration', 'armGroupLabels': ['1: Tramadol HCl 200 mg daily or placebo', '2: Tramadol HCl 400 mg daily or placebo', '3: Tramadol HCl 600 mg daily or placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Size-matching capsules containing an appropriate inactive excipient', 'armGroupLabels': ['1: Tramadol HCl 200 mg daily or placebo', '2: Tramadol HCl 400 mg daily or placebo', '3: Tramadol HCl 600 mg daily or placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Janssen Scientific Affairs, LLC Clinical trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Scientific Affairs, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, {'name': 'Cipher Pharmaceuticals Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}