NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

Study Overview
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Brief Summary
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This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.

Official Title
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NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

Conditions
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Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)

Intervention / Treatment
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* Drug: Buprenorphine Transdermal System
* Drug: Buprenorphine Transdermal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age are ≥20 ,≤80 years. Clinical diagnosis of musculoskeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1. Subject is a current user of NSAIDS or paracetamol and reports a history of insufficient therapeutic benefit in musculoskeletal pain. Subjects must record an 'average pain over the last week at study institution' score at primary pain site of ≥ 4 on an 11-point numerical pain rating scale. Subjects must be able to understands the study procedures and assessment, and agree to participate in the study by giving written informed consent. Exclusion Criteria: Subjects who have been taking long-acting or short-acting opioid analgesic formulations within the last 4 weeks. Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to their musculoskeletal 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 including leukemia and lymphoma. 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 a current or past (within 5 years) 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. Females who are pregnant, lactating or have a possibility of being pregnant. Subjects with values > 2 times the upper limit of normal for AST or ALT or total bilirubin at visit 1 or who have severe impaired liver function. Subjects with serum creatinine > 2 mg/dL at Visit 1 or who have severe impaired renal function. Subjects with serum potassium < 3.5 mEq/L at Visit 1. Subjects receiving hypnotics or other central nervous system (CNS) depressants. Subjects receiving monoamine oxidase inhibitor (MAOI) within 2 weeks before screening. Subjects who have a history of supersensitivity to study drug. Known intolerance to and/or lack of effect of tramadol. Subjects who participated in a clinical research study within 1 month of study entry. Subjects who participated previously in a BTDS study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buprenorphine Transdermal System<br> | Drug: Buprenorphine Transdermal System<br>* Titration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given. maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control .<br>|
| Active Comparator: Tramadol CR<br> | Drug: Buprenorphine Transdermal System<br>* Titration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given. maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline |  | 11 weeks |