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| Sponsor: | Janssen Pharmaceutical K.K. |
|---|---|
| Information provided by: | Janssen Pharmaceutical K.K. |
| ClinicalTrials.gov Identifier: | NCT01124604 |
Purpose
The objective of the study is to investigate the effectiveness,safety of JNS024ER (now known as and referred to throughout this posting as Tapentadol ER) at doses 25-250 mg twice daily, and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) in Japanese patients with moderate to severe chronic pain due to osteoarthritis of the knee or low back pain (LBP).
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Low Back Pain Back Pain Osteoarthritis |
Drug: Tapentadol ER Drug: Placebo |
Phase II |
| 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: | Phase 2 Study of JNS024ER in Patients With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain |
| Enrollment: | 91 |
| Study Start Date: | April 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
Tapentadol ER 25mg 50mg and100mg tablets (50-500 mg/day) twice daily for 12 weeks
|
Drug: Tapentadol ER
25mg, 50mg and100mg tablets (50-500 mg/day) twice daily for 12 weeks
|
|
Experimental: 002
Placebo placebo tablets twice daily for 12 weeks
|
Drug: Placebo
placebo tablets twice daily for 12 weeks
|
This is a randomized (study drug assigned by chance), multicenter, double-blind (neither physician nor patient knows the name of the assigned drug), placebo-control (patients are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug) parallel-group (participants receive the same intervention throughout the protocol) comparison study in the patients with chronic pain due to osteoarthritis of the knee or low back pain. The study will be explained and informed consent will be obtained. Patients will be screened for study eligibility at Visit 1. Potential patients must satisfy all eligibility criteria to be enrolled in the study. Eligible candidates will proceed to the study treatment period. At the time of study entry, all prohibited medications will be discontinued and will be disallowed throughout the study. The study consists of 3 periods: a 1-week screening period during which patients are evaluated for study eligibility; a 12-week study treatment period (maximum of 6-week dose adjustment phase and minimum of 6-week of dose maintenance phase); and a one-week follow-up period. The sponsor will collect adverse events starting with the signing of the informed consent form until the follow up period. Adverse events include any occurrence that is new in onset or gets worse in severity or frequency from the baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities. Blood samples for serum chemistry and hematology, a urine sample for urinalysis, vital signs, 12-lead electrocardiography and clinical opioid withdrawal symptoms questionnaire will be also collected for safety evaluation. Numerical Rating Scale, Sleep questionnaire, Brief Pain Inventory Short Form, Western Ontario MacMaster Questionnaire (only for patients with osteoarthritis [OA] of the knee), Roland Morris Disability Questionnaire (only for patients with LBP), Short Form 36 Health Survey, Patient's global impression of change and Physician's global assessment will be collected for efficacy evaluation. Serum drug concentrations will also collected for pharmacokinetic evaluation. Patients will be randomized to one of the two following treatment groups: Tapentadol ER group and Placebo group. Tapentadol ER or placebo will be administered orally twice daily in the morning and evening. The dose ranges is between 50 and 500 mg/day. The maximum dose is 250 mg/intake (500 mg/day). The investigator determines (based on consultation at patient visits and the patient diary) whether or not the dose may be increased. Tapentadol ER or placebo will be administered orally twice daily in the morning and evening. The dose range is between 50 and 500 mg/day. The maximum dose is 250 mg/intake (500 mg/day). The 12-week treatment period consists of two phases: maximum of 6-week dose adjustment phase and minimum of 6-week dose maintenance phase.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Director of Clinical R&D Dept. 3, Janssen Pharmaceutical K.K., Japan |
| ClinicalTrials.gov Identifier: | NCT01124604 History of Changes |
| Other Study ID Numbers: | CR016999, JNS024ER-JPN-N21 |
| Study First Received: | April 22, 2010 |
| Last Updated: | January 27, 2011 |
| Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
|
Tapentadol Tapentadol ER JNS024ER |
Chronic Pain Low Back Pain Osteoarthritis |
|
Back Pain Low Back Pain Osteoarthritis Osteoarthritis, Knee Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |