A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute… (NCT00613938) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
United States901 participantsStarted 2008-02
Plain-language summary
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.
Who can participate
Age range18 Years – 80 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:
* 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.
Exclusion Criteria:
* 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).
What they're measuring
1
Sum of Pain Intensity Difference Over 48 Hours (SPID48)
Timeframe: 48 hours
Trial details
NCT IDNCT00613938
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.