Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 11:33 AM
Study NCT ID:
NCT00419692
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2007-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046649', 'term': 'ropinirole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2006-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2007-01-05', 'studyFirstSubmitQcDate': '2007-01-05', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration', 'timeFrame': 'dosing interval'}], 'secondaryOutcomes': [{'measure': 'Time to attain the maximum plasma concentration Time taken for ropinirole concentration to fall to half initial value Incidence of adverse events Vital signs, ECG and clinical laboratory data As above, but for ropinirole metabolites', 'timeFrame': 'Time taken for ropinirole concentration to fall to half initial value'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetic,', 'RLS', 'formulation,', 'food effect,', 'controlled release for RLS,', 'SK&F101468,'], 'conditions': ['Restless Legs Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/ROR106470?search=study&search_terms=ROR106470#rs', 'label': 'Results for study ROR106470 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with a diagnosis of RLS\n* Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg\n* Normal blood pressure pre-study\n* Light smokers only (\\<20/day)\n\nExclusion criteria:\n\n* History of postural hypotension or faints\n* Secondary RLS\n* Patients who suffer from a primary sleep disorder other than RLS\n* Patients diagnosed with movement disorders\n* Patients with unstable medical conditions\n* Patients with personal or family history of adverse reactions or hypersensitivity to the study drug\n* Patients with abnormal laboratory values\n* Patients with hepatitis or HIV\n* Patients who abuse alcohol or drugs\n* Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa'}, 'identificationModule': {'nctId': 'NCT00419692', 'briefTitle': 'Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for RLS', 'orgStudyIdInfo': {'id': 'ROR106470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence WAXBYZCDE', 'description': 'Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), C: 1 x 6 mg CR-RLS (fasted), D: 1 x 6 mg CR-RLS (high fat fed) and E: 2 x 3 mg CR-RLS (fasted).', 'interventionNames': ['Drug: Ropinirole']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence WAXBYZCED', 'description': 'Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), C: 1 x 6 mg CR-RLS (fasted), E: 2 x 3 mg CR-RLS (fasted) and D: 1 x 6 mg CR-RLS (high fat fed).', 'interventionNames': ['Drug: Ropinirole']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence WAXBYZDCE', 'description': 'Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), D: 1 x 6 mg CR-RLS (high fat fed), C: 1 x 6 mg CR-RLS (fasted) and E: 2 x 3 mg CR-RLS (fasted).', 'interventionNames': ['Drug: Ropinirole']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence WAXBYZDEC', 'description': 'Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), D: 1 x 6 mg CR-RLS (high fat fed), E: 2 x 3 mg CR-RLS (fasted) and C: 1 x 6 mg CR-RLS (fasted).', 'interventionNames': ['Drug: Ropinirole']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence WAXBYZECD', 'description': 'Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), E: 2 x 3 mg CR-RLS (fasted),C: 1 x 6 mg CR-RLS (fasted) and D: 1 x 6 mg CR-RLS (high fat fed).', 'interventionNames': ['Drug: Ropinirole']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence WAXBYZEDC', 'description': 'Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), E: 2 x 3 mg CR-RLS (fasted), D: 1 x 6 mg CR-RLS (high fat fed) and C: 1 x 6 mg CR-RLS (fasted).', 'interventionNames': ['Drug: Ropinirole']}], 'interventions': [{'name': 'Ropinirole', 'type': 'DRUG', 'description': 'Subjects will receive ropinirole 0.5 mg for first 7 days, 1 mg from Day 8-14, 2 mg from Day 15-21, 3 mg from Day 22-28, 4 mg from Day 29-35, 5 mg from Day 36-42 and 6 mg from Day 43-51.', 'armGroupLabels': ['Sequence WAXBYZCDE', 'Sequence WAXBYZCED', 'Sequence WAXBYZDCE', 'Sequence WAXBYZDEC', 'Sequence WAXBYZECD', 'Sequence WAXBYZEDC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '6530', 'city': 'George', 'country': 'South Africa', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}