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An Efficacy and Safety Study for Tapentadol ER (JNS024ER) in Chronic Pain Patients
This study has been completed.

First Received on April 22, 2010.   Last Updated on January 27, 2011   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Change in Pain Scores on the Numerical Rating Scale [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Health Related Quality of Life Scores on the Short Form 36 Health Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Pain Scores on the Brief Pain Inventory Short Form [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sleep Questionnaire items to evaluate patients' quality of sleep [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

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

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Patients with chronic pain due to osteoarthritis of the knee or low back pain continuing for at least 12 weeks before informed consent
  • Patients with non-opioid treatment and dissatisfied with current treatment (Routine treatment with an oral non-opioid analgesic at its usual upper-limit dose for at least 14 consecutive days during the 12 weeks before informed consent, or patients who are continuously taking a non-opioid analgesic at a certain dose (except the use on an as-needed base) at least 14 consecutive days at informed consent although the dose is less than the normal highest dose because of being unable to receive treatment at the normal highest dose or more for medical reasons such as safety)
  • Patients have not experienced treatment with conventional opioids, except for a) Short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or b)Temporal use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
  • Mean pain intensity score of >= 5 on an 11-point Numerical Rating Scale during 48 hours before informed consent and the investigator/sub-investigator considers that the subject should be treated with an opioid analgesic

Exclusion Criteria:

  • Patients have been treated or treated with a monoamine oxidase inhibitor within 14 days before informed consent
  • Current or a history of epilepsy or convulsive disorders
  • Suggested of intracranial hypertension (e.g. traumatic encephalopathy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124604

Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

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

Keywords provided by Janssen Pharmaceutical K.K.:
Tapentadol
Tapentadol ER
JNS024ER
Chronic Pain
Low Back Pain
Osteoarthritis

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Osteoarthritis
Osteoarthritis, Knee
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012