A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthralgia, Bunion, Hallux Valgus, Pain

In brief

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.

Key facts

Study ID

NCT00613938

Run by

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

People needed

901

Starts

2008-02-01

Expected to finish

2008-10-01

Last updated by the study team

2014-05-09

Who can join

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

You may qualify if…

• Patients must undergo primary unilateral first metatarsal bunionectomy
• Pain intensity must be moderate to severe following removal of a continuous popliteal sciatic block
• Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active.

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 severe renal insufficiency
• Moderately or severely impaired hepatic function
• Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).

Where it is running

• Study site — Glendale, California, United States
• Study site — Pasadena, Maryland, United States
• Study site — Austin, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — San Marcos, Texas, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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