Clinical trial NCT01643759: Norspan Transdermal Patches Study in Osteoarthritis Patients
Official title: A Single Dose PK Study of BTDS 5, 10, and 20 in Chinese Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis Disorders
Keywords: osteoarthritis disorders
Lead sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site: Peking Union Medical Hospital(PUMC)
Study officials:
affiliation: Mundipharma China Ltd.
name: Mundipharma China Ltd.
role: STUDY_CHAIR
References: