A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of V… (NCT00657449) | Clinical Trial Compass
TerminatedPhase 4
A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain
Stopped: See termination reason in detailed description.
Brazil45 participantsStarted 2003-06-04
Plain-language summary
The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the disability status, tolerability and safety of these treatments.
Who can participate
Age range
18 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 had sustained, no more than 48 hours prior to the first dose of study medication, a first- or second-degree ankle sprain of the lateral ligament, specifically: anterior talofibular ligament and/or posterior talofibular ligament and/or calcaneofibular ligament
* At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual Analog Scale (VAS) (0-100mm) of ≥45 mm in the orthostatic position on full weight bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
* Tthe investigator opinion was that each patient required, and was eligible for, therapy with an anti-inflammatory agent and/or analgesics to control symptoms
Exclusion Criteria:
None reported
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
change from baseline in visual analogue scale (VAS) pain intensity