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Norspan Transdermal Patches Study in Osteoarthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01643759
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : July 8, 2015
Information provided by (Responsible Party):
Mundipharma (China) Pharmaceutical Co. Ltd

Brief Summary:
This is a single center, open label, randomized, parallel group single dose pharmacokinetic (PK) study.

Condition or disease Intervention/treatment Phase
Osteoarthritis Disorders Drug: buprenorphine Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose PK Study of BTDS 5, 10, and 20 in Chinese Osteoarthritis Patients
Study Start Date : July 2009
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: buprenorphine transdermal system
buprenorphine transdermal system
Drug: buprenorphine
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.
Other Name: Norspan

Primary Outcome Measures :
  1. Area Under Curve (AUC) [ Time Frame: Pre-dose, 6hr, 12hr, 24hr, 36hr, 48hr, 60hr, 72hr, 96hr, 120hr, 144hr,168hr, 169hr, 170hr, 171hr, 172hr, 174hr, 180hr, 192hr, 216hr, 240hr post dose. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients volunteering for participation in the study.
  • Male and female patients with diagnosis of osteoarthritis, age from 20 to 60 years.
  • Body weight ≥ 50kg , and BMI range ≧ 18.5, ﹤ 30.
  • 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.
  • Agreed not to use any medication (except vitamins or mineral supplements) during the course of the study.
  • 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.
  • Females of childbearing potential must have a negative serum pregnancy test during screening visit and at check-in.

Exclusion Criteria:

  • Subjects who have been taking opioid analgesic formulations excess 7 days within 3 months of Visit 1.
  • Subjects who have been taking CYP3A4 inhibitor or inducer within the last 1 month prior to the screening visit.
  • 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.
  • 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.
  • Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis.
  • Subject who have a past history of malignant neoplasm.
  • Subjects with clinically unstable, active or symptomatic heart disease.
  • Subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on.
  • Subjects who have any medical or surgical conditions that might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
  • History of frequent nausea or emesis regardless of etiology.
  • 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.
  • Subjects scheduled for therapies within the study period which might effect study assessment.
  • 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.
  • Subjects with serum creatinine > 2 mg/dL during the Screening Period or who have severe impaired renal function.
  • Subjects with serum potassium < 3.5 mEq/L during the Screening Period.
  • Subjects with positive result of anti-human immunodeficiency virus antibodies, hepatitis B surface antigen, hepatitis C virus antibody or qualitative syphilis tests.
  • 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.
  • Subjects who have a history of supersensitivity to study drug.
  • Subjects who participated in a clinical research study within 1 month of study entry.
  • Subjects who participated previously in a BTDS study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01643759

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Investigational Site: Peking Union Medical Hospital(PUMC)
Beijing, China
Sponsors and Collaborators
Mundipharma (China) Pharmaceutical Co. Ltd
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Study Chair: Mundipharma China Ltd. Mundipharma China Ltd.
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Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd Identifier: NCT01643759    
Other Study ID Numbers: BP08-CN-002
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Keywords provided by Mundipharma (China) Pharmaceutical Co. Ltd:
osteoarthritis disorders
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists