An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain

Completed · Phase 3

Conditions studied: Pain, Osteoarthritis, Low Back Pain

In brief

The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the long term; characterize adverse events and tolerability, sleep quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall impression of change; and characterize patient-related health outcomes.

Key facts

Study ID

NCT00487435

Run by

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

People needed

1166

Starts

2007-06-01

Expected to finish

2009-06-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-lactating female subjects (Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control [e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization] before entry and throughout the trial. Female patients of childbearing potential must have a negative pregnancy test at screening.)
• Completion of the expected double-blind treatment period of the pivotal Tapentadol (CG5503) Phase 3 trials in osteoarthritis (R331333-PAI-3008, KF5503/11) or low back pain (R331333-PAI-3011, KF5503/23), or completion of the 1-year treatment period of the safety CG5503 Phase 3 trial in the non-European sites (R331333-PAI-3007, KF5503/24)
• Must be willing to take Tapentadol (CG5503) extended release (ER) and the rescue medication supplied for the duration of the trial

You may not qualify if…

• History of alcohol and/or drug abuse, life-long history of seizure disorder or epilepsy, any of the following within the past year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
• Severe traumatic brain injury within the past 15 years
• Uncontrolled hypertension (repeated systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg)
• Severely impaired renal function
• Moderately or severely impaired hepatic function
• Patients taking neuroleptics, monoamine oxidase inhibitors, or tricyclic antidepressants within 14 days prior to screening.

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Carmichael, California, United States
• Study site — Encinitas, California, United States
• Study site — Fresno, California, United States
• Study site — Huntington Park, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Los Gatos, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Upland, California, United States
• Study site — Westlake Village, California, United States
• Study site — Stamford, Connecticut, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Chiefland, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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