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 range
18 Years – 80 Years
Sex
ALL
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.