NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

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

Study Overview

• Status: Completed
• Conditions: Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)
• Intervention / Treatment: Drug: Buprenorphine Transdermal System

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Investigational Site:Peking Union Medical Hospital (PUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Buprenorphine Transdermal System	Drug: Buprenorphine Transdermal System; 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 .
ACTIVE_COMPARATOR: Tramadol CR	Drug: Buprenorphine Transdermal System; 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 .

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd

Publications and helpful links

General Publications

• Leng X, Li Z, Lv H, Zheng Y, Liu Y, Dai K, Yao C, Yan X, Zeng X. Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study. Clin J Pain. 2015 Jul;31(7):612-20. doi: 10.1097/AJP.0000000000000144.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: November 17, 2011
• First Posted (ESTIMATE): November 22, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 7, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Disease; Spinal Cord Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: BP08-CN-001