NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

NCT ID: NCT01476774

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Buprenorphine Transdermal System

Group Type: ACTIVE_COMPARATOR

Buprenorphine Transdermal System

Intervention Type: DRUG

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 .

Tramadol CR

Group Type: ACTIVE_COMPARATOR

Buprenorphine Transdermal System

Intervention Type: DRUG

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 .

Interventions

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 .

Intervention Type: 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 .

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma (China) Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mundipharma China Ltd.

Role: STUDY_CHAIR

Mundipharma China Ltd.

Locations

Investigational Site:Peking Union Medical Hospital (PUMC)

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 25503600 (View on PubMed)

Other Identifiers

BP08-CN-001

Identifier Type: -

Identifier Source: org_study_id