A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Arthroplasty

In brief

The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.

Key facts

Study ID

NCT00364533

Run by

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

People needed

367

Starts

2006-10-01

Expected to finish

2007-12-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to degenerative joint disease (arthritis), not due to some inflammatory process, (eg. infection)
• Baseline pain intensity >= 4 on an 11-point (0 to 10) Pain Intensity rating scale, rated within 30 minutes before randomization
• Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the study

You may not qualify if…

• Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
• history of malignancy within the past 2 years before starting the study
• history of alcohol or drug abuse
• evidence of active infections that may spread to other areas of the body
• clinical laboratory values reflecting moderate or severe kidney insufficiency
• currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or selective norepinephrine reuptake inhibitor (SNRI), (selective serotonin reuptake inhibitor [SSRI] treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose)

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Sheffield, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Fort Smith, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Arcadia, California, United States
• Study site — Glendale, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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