NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain
This study has been completed.
Sponsor:
Mundipharma
Information provided by (Responsible Party):
Mundipharma
ClinicalTrials.gov Identifier:
NCT01476774
First received: November 17, 2011
Last updated: August 27, 2012
Last verified: April 2012
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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:
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 More Information
No publications provided
| Responsible Party: | Mundipharma |
| 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 May 19, 2013