search
Back to results

NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Buprenorphine Transdermal System
Buprenorphine Transdermal System
Sponsored by
Mundipharma (China) Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site:Peking Union Medical Hospital (PUMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Buprenorphine Transdermal System

Tramadol CR

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 17, 2011
Last Updated
July 7, 2015
Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT01476774
Brief Title
NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain
Official Title
NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine Transdermal System
Arm Type
Active Comparator
Arm Title
Tramadol CR
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Transdermal System
Intervention Description
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
Intervention Name(s)
Buprenorphine Transdermal System
Intervention Description
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 .
Primary Outcome Measure Information:
Title
The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mundipharma China Ltd.
Organizational Affiliation
Mundipharma China Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site:Peking Union Medical Hospital (PUMC)
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25503600
Citation
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.
Results Reference
derived

Learn more about this trial

NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

We'll reach out to this number within 24 hrs