Norspan Transdermal Patches Study in Osteoarthritis Patients

Phase 1

Completed

• Conditions: Osteoarthritis Disorders
• Interventions: Drug: buprenorphine

• Registration Number: NCT01643759
• Lead Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-03
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
buprenorphine transdermal system	buprenorphine	buprenorphine transdermal system

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	Pre-dose, 6hr, 12hr, 24hr, 36hr, 48hr, 60hr, 72hr, 96hr, 120hr, 144hr,168hr, 169hr, 170hr, 171hr, 172hr, 174hr, 180hr, 192hr, 216hr, 240hr post dose.

Trial Locations

Locations (1)

Investigational Site: Peking Union Medical Hospital(PUMC); 🇨🇳 Beijing, China