Status:
COMPLETED
NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain
Lead Sponsor:
Mundipharma (China) Pharmaceutical Co. Ltd
Conditions:
Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT01476774
Start Date
August 1 2009
Last Update
July 8 2015
Active Locations (1)
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1
Investigational Site:Peking Union Medical Hospital (PUMC)
Beijing, China