A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain

Completed · Phase 3

Conditions studied: Osteoarthritis, Hip, Osteoarthritis, Knee, Lower Back Pain, Pain

In brief

The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.

Key facts

Study ID

NCT00361504

Run by

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

People needed

1123

Starts

2006-11-01

Expected to finish

2008-07-01

Last updated by the study team

2014-04-29

Who can join

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

You may qualify if…

• Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
• Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
• Have a pain intensity >4 on Numerical Rating Scale

You may not qualify if…

• Life-long history of seizure disorder or epilepsy
• Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
• Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
• History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
• Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Cudahy, California, United States
• Study site — Encinitas, California, United States
• Study site — San Diego, California, United States
• Study site — Westlake Village, California, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Chiefland, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Oldsmar, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Cumming, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Perry, Georgia, United States
• Study site — Suwanee, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Prairie Village, Kansas, United States
• Study site — Topeka, Kansas, United States
• Study site — Paducah, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Rockville, Maryland, United States
• Study site — Wellesley Hills, Massachusetts, United States
• Study site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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