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

NCT00364546 | Completed Phase 3

• 1 other identifier: CR011212
• Study Type: interventional
• Target: 877
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis; Pain Intensity Assessment; Arthralgia; Sciatica; Low Back Pain

Keywords

Osteoarthritis; Pain; Low Back Pain; Hip Pain; Knee Pain; Backache; tapentadol

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

CG 5503;tapentadol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Grünenthal GmbH: collaborator

Related Publications (2)

• Vorsanger G, Xiang J, Biondi D, Upmalis D, Delfgaauw J, Allard R, Moskovitz B. Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients. Pain Res Manag. 2011 Jul-Aug;16(4):245-51. doi: 10.1155/2011/323985.

  PMID: 22059194 DERIVED

• Hale M, Upmalis D, Okamoto A, Lange C, Rauschkolb C. Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: a randomized, double-blind study. Curr Med Res Opin. 2009 May;25(5):1095-104. doi: 10.1185/03007990902816970.

  PMID: 19301989 DERIVED

Related Links

• A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 (Tapentadol HCl) Immediate Release or Oxycodone Immediate Release in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee

MeSH Terms

Conditions

Osteoarthritis; Arthralgia; Sciatica; Low Back Pain; Pain; Back Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2007
• Last Updated: June 9, 2011

Record last verified: 2010-04