NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

NCT01476774 | Completed Phase 3

• 1 other identifier: BP08-CN-001
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline

  11 weeks

Study Arms (2)

Buprenorphine Transdermal System

ACTIVE COMPARATOR

Drug: Buprenorphine Transdermal System

Tramadol CR

ACTIVE COMPARATOR

Drug: Buprenorphine Transdermal System

Interventions

Buprenorphine Transdermal System 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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (1)

Investigational Site:Peking Union Medical Hospital (PUMC)

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 25503600 DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mundipharma China Ltd.

  Mundipharma China Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 22, 2011
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

CN (1)