CompletedPhase 3

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

877 participantsStarted 2006-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00364546

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-06

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