Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)
Conditions
Brief summary
This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.
Interventions
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 .
Sponsors
Mundipharma (China) Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline | 11 weeks |
Countries
China
Outcome results
None listed