A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00364546
First received: August 11, 2006
Last updated: June 2, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain.


Condition Intervention Phase
Osteoarthritis
Pain Intensity Assessment
Arthralgia
Sciatica
Low Back Pain
Drug: CG 5503;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-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.

Secondary Outcome Measures:
  • The secondary outcomes, among others, include COWS and SOWS assessments; patient assessment of constipation symptoms; vomiting and sleep assessments; pain intensity assessment; patient global impression of change.

Enrollment: 877
Study Start Date: July 2006
Study Completion Date: July 2007
Primary Completion Date: June 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 is designed to assess the safety of CG5503 Immediate Release (IR) in men and women who are 18 years of age or older and who have had chronic (for at least 3 months) low-back pain or chronic pain from osteoarthritis of the hip or knee, and who require daily analgesic medication. In this double blind study (neither patients nor investigators will know what treatment is given), patients will be randomly (patients are assigned different treatments based on chance) assigned to receive either CG5503 base IR or oxycodone IR to begin a 90 day treatment during which each patient will return to the medical facility every 2 weeks. For the CG5503 IR group, patients will take 50 or 100 mg orally every 4 to 6 hours as needed to a maximum dose of 600 mg per day. Oxycodone IR patients will take 10 or 15 mg orally every 4 to 6 hours as needed to a maximum dose of 90 mg per day. Patients may continue taking their regular, stable, non-opioid medication throughout the study. The effectiveness of study treatment (CG5503 base IR or oxycodone) will be assessed with 11-Point Numerical Rating Scale and Patient Global Impression of Change. Using these scales, patients will indicate their pain intensity level and overall status of their well-being. Opioid withdrawal symptoms of CG5503 IR dose of 50 or 100 mg will be assessed with clinical opioid withdrawal scale [Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale (COWS)] at the end of treatment. Using these scales, patients will indicate the physical components of drug withdrawal and the severity of symptoms associated with rapid withdrawal. Safety will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead electrocardiogram (ECG) results. Constipation, vomiting, and sleep assessments will be performed. No formal hypothesis testing will be done in this study. For the CG5503 IR group, patients will take a flexible dose of 50 or 100 mg orally every 4 to 6 hours as needed to a maximum dose of 600 mg per day for 90 days. Oxycodone IR patients will take a flexible dose of 10 or 15 mg orally every 4 to 6 hours as needed to a maximum dose of 90 mg per day for 90 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of one of the following: low-back pain of non-malignant origin for at least 3 months, osteoarthritis of the knee or hip for at least 3 months
  • require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief Ladder
  • post-washout baseline pain intensity score >4 on an 11-point numerical rating scale

Exclusion Criteria:

  • History of seizure disorder or epilepsy
  • uncontrolled hypertension
  • currently treated with monoamine oxidase inhibitors
  • systemic steroid therapy, excluding inhalers or topical steroids, within 3 months before screening
  • history of malignancy within the past 2 years, with the exception of basal cell carcinoma
  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: NCT00364546

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 by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00364546     History of Changes
Other Study ID Numbers: CR011212
Study First Received: August 11, 2006
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Osteoarthritis
Pain
Low Back Pain
Hip Pain
Knee Pain
Backache
tapentadol

Additional relevant MeSH terms:
Arthralgia
Back Pain
Low Back Pain
Osteoarthritis
Sciatica
Chronic Pain
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Arthritis
Rheumatic Diseases
Neuralgia
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014