NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01476774
First received: November 17, 2011
Last updated: August 27, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)
Drug: Buprenorphine Transdermal System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: August 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 .


  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476774

Locations
China
Investigational Site:Peking Union Medical Hospital (PUMC)
Beijing, China
Sponsors and Collaborators
Mundipharma Pte Ltd.
Investigators
Study Chair: Mundipharma China Ltd. Mundipharma China Ltd.
  More Information

No publications provided

Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT01476774     History of Changes
Other Study ID Numbers: BP08-CN-001
Study First Received: November 17, 2011
Last Updated: August 27, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Disease
Intervertebral Disk Displacement
Intervertebral Disk Degeneration
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014