Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-06 @ 10:44 AM
Study NCT ID:
NCT01643759
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2011-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norspan Transdermal Patches Study in Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-07', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve (AUC)', 'timeFrame': 'Pre-dose, 6hr, 12hr, 24hr, 36hr, 48hr, 60hr, 72hr, 96hr, 120hr, 144hr,168hr, 169hr, 170hr, 171hr, 172hr, 174hr, 180hr, 192hr, 216hr, 240hr post dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis disorders'], 'conditions': ['Osteoarthritis Disorders']}, 'descriptionModule': {'briefSummary': 'This is a single center, open label, randomized, parallel group single dose pharmacokinetic (PK) study.', 'detailedDescription': 'After up to 7-day screening period, Eligible Patients will be randomized to 1 of 3 treatment groups, and begin treatment with BTDS 5mg, 10mg,20mg for 7 days.Venous blood will be collected at 0, 6, 12, 24, 36, 48, 60, 72, 96,120, 144,168,169,170,171,172,174,180,192,216, 240 h postdose respectively.Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, Tmax, t½.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients volunteering for participation in the study.\n* Male and female patients with diagnosis of osteoarthritis, age from 20 to 60 years.\n* Body weight ≥ 50kg , and BMI range ≧ 18.5, ﹤ 30.\n* Having the results within the following ranges and having been judged as eligible for the study participation by the investigator:Systolic blood pressure (supine), 90-140 mm Hg,Diastolic blood pressure (supine), 60-90 mm Hg, Armpit body temperature, 35.0-37.5 degree Celsius.\n* Agreed not to use any medication (except vitamins or mineral supplements) during the course of the study.\n* Have not smoked or chewed tobacco for at least 45 days prior to dosing with study drugs, and agree not to use tobacco products during the study.\n* Females of childbearing potential must have a negative serum pregnancy test during screening visit and at check-in.\n\nExclusion Criteria:\n\n* Subjects who have been taking opioid analgesic formulations excess 7 days within 3 months of Visit 1.\n* Subjects who have been taking CYP3A4 inhibitor or inducer within the last 1 month prior to the screening visit.\n* Subjects who have been taking any medication including OTC (except vitamin and/or mineral supplements) within 7 days prior to the first dose of the trial product.\n* Patients who have a current chronic disease(s), or who have a past history and high possibilities to relapse, in addition to their musculo-skeletal pain, requiring frequent analgesic therapy.\n* Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis.\n* Subject who have a past history of malignant neoplasm.\n* Subjects with clinically unstable, active or symptomatic heart disease.\n* Subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on.\n* Subjects who have any medical or surgical conditions that might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.\n* History of frequent nausea or emesis regardless of etiology.\n* Subjects who have a current or past history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period.\n* Subjects scheduled for therapies within the study period which might effect study assessment.\n* Subjects with values \\> 2 times the upper limit of normal for AST or ALT or total bilirubin during the Screening Period or who have severe impaired liver function.\n* Subjects with serum creatinine \\> 2 mg/dL during the Screening Period or who have severe impaired renal function.\n* Subjects with serum potassium \\< 3.5 mEq/L during the Screening Period.\n* Subjects with positive result of anti-human immunodeficiency virus antibodies, hepatitis B surface antigen, hepatitis C virus antibody or qualitative syphilis tests.\n* Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within 1 month prior to the start of the study.\n* Subjects who have a history of supersensitivity to study drug.\n* Subjects who participated in a clinical research study within 1 month of study entry.\n* Subjects who participated previously in a BTDS study.'}, 'identificationModule': {'nctId': 'NCT01643759', 'briefTitle': 'Norspan Transdermal Patches Study in Osteoarthritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma (China) Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Single Dose PK Study of BTDS 5, 10, and 20 in Chinese Osteoarthritis Patients', 'orgStudyIdInfo': {'id': 'BP08-CN-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'buprenorphine transdermal system', 'description': 'buprenorphine transdermal system', 'interventionNames': ['Drug: buprenorphine']}], 'interventions': [{'name': 'buprenorphine', 'type': 'DRUG', 'otherNames': ['Norspan'], 'description': 'The subjects will be randomized to receive either a single dose of BTDS 5, or BTDS 10, or BTDS 20 for 7 days. Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t:pg•hr/ml-Area under the plasma concentration-time curve frame: predose,6,12,24,36,48,60,72,96,120,144,168,169,170,171,172,174,180,192,216,240 hours post-dose.AUC0-inf:pg•hr/ml-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: pg/ml-Maximum observed plasma buprenorphine concentration. Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of buprenorphine elimination.', 'armGroupLabels': ['buprenorphine transdermal system']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Investigational Site: Peking Union Medical Hospital(PUMC)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Mundipharma China Ltd.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mundipharma China Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma (China) Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}