Clinical trial NCT01476774: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)
Lead sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site:Peking Union Medical Hospital (PUMC)
Study officials:
affiliation: Mundipharma China Ltd.
name: Mundipharma China Ltd.
role: STUDY_CHAIR
References:
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.