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A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement Surgery

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00361582
First received: August 4, 2006
Last updated: June 3, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to evaluate in patients who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis the efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR patients.


Condition Intervention Phase
Osteoarthritis
Pain Assessment
Arthralgia
Drug: CG5503 IR; tapentadol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The primary efficacy outcome is the SPID (Sum of Pain Intensity Difference) calculated at 5 days.

Secondary Outcome Measures:
  • Secondary efficacy outcomes include, among others, the time to the first use of rescue medication, the distribution of responder rates, and the SPID over 2 and 10 days.

Enrollment: 669
Study Start Date: October 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

CG5503 is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study was designed to assess the safety and tolerability of CG5503 IR in patients who need joint replacement of the hip or knee due to chronic osteoarthritis. This is a double-blind study, i.e., neither patients nor investigators will know what treatment is given. Before the start of the 10 day double-blind phase, each patient will be screened for eligibility and eligible patients will be randomly assigned to receive either CG5503 IR, oxycodone IR, or placebo (i.e., no active drug). All patients will take their treatment by mouth every 4 to 6 hours during waking hours. A total of 60 doses (up to 6 doses per day) of study treatment will be provided for each patient during the 10-day treatment phase. The study treatment will be dispensed on Day 1, and patients will take the first dose in the evening of the same day. The effectiveness of study treatment (CG5503 IR, oxycodone, or placebo) will be assessed using several measures, including 11 Point Pain Numerical Rating Scale, 5-Point Relief Numerical Rating Scale, and Patient Global Impression of Change. Using these scales, patients will indicate their pain intensity level, pain relief level, and overall status of their well-being. Safety and tolerability will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead ECG results. The null hypothesis for the study is that all CG5503 IR dosage efficacy results are equal to placebo based on the 5-day SPID in the treatment of chronic pain caused by osteoarthritis. The alternative study hypothesis is that at least 1 CG5503 IR dose effect will be different from placebo effect. CG5503 IR 50 mg, 75 mg of the base, 10 mg oxycodone or placebo for 10 days taken by mouth every 4 to 6 hours during waking hours. Patients randomized to CG5503 IR 75 mg group will receive CG5503 IR 50 mg on Day 1 and 75 mg on Day 2 to 10. All doses of study treatment should be taken with approximately 120 mL of water with or with food.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of chronic osteoarthritis of the hip or the knee based on clinical and radiographic (X-Ray) criteria defined by standard accepted guidelines
  • candidate (qualifies) for primary one-sided total or partial joint replacement surgery due to noninflammatory, end-stage degenerative joint disease (arthritis)
  • requires daily doses of analgesic medication for chronic pain.

Exclusion Criteria:

  • History of seizure disorder or epilepsy suggested by the presence of any of the following
  • History of chronic hepatitis B and C or human immunodeficiency virus, or presence of active hepatitis B and C within the past 3 months before screening
  • currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressant, neuroleptics, or serotonin norepinephrine reuptake inhibitors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361582

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00361582     History of Changes
Other Study ID Numbers: CR011218
Study First Received: August 4, 2006
Last Updated: June 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Osteoarthritis
tapentadol
knee-replacement
hip replacement
pain

Additional relevant MeSH terms:
Arthralgia
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Pain
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014