Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprai
- Conditions
- -S934 Sprain and strain of ankleSprain and strain of ankleS934
- Registration Number
- PER-120-06
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient with> 18 years of age.
2. Patient with the first episode of ankle sprain in the last 6 months, classified as First or Second Degree, confirmed by X-rays.
3. The patient must have suffered a sprained ankle, no more than 48 hours before, of the first dose of the study medication.
4. The patient presents a pain measurement on the Visual Analogue Scale (VAS)> 45 mm, in conditions of total weight support.
5. If a woman, must be postmenopausal, surgically sterile, or be using an appropriate contraceptive method, without breastfeeding, with a negative urine pregnancy test at the time of selection, prior to the administration of study medication.
6. The patient has provided written informed consent prior to admission into this study.
1. The patient presents a similar lesion in the same joint in the last six months; or clinical evidence of a complete rupture of the ankle ligaments, or requires bed rest, hospitalization, surgical intervention or evidence of fracture, complete splint, non-removable of any kind, presence of a bilateral ankle injury or ankle injury ipsilateral and knee.
2. The patient has a diagnosis of osteoarthritis and is currently under active therapy.
3. The patient is experiencing acute pain different from that of ankle sprain.
4. The patient presents clinically important signs and symptoms suggestive of morbid renal or hepatic conditions.
5. The patient is considered with a reduced volume of fluids.
6. The patient is being treated for any type of infection or for the clinical suspicion of infection.
7. The patient is currently on anticoagulants, or at that time has a coagulopathy that is clinically significant.
8. The patient has received an intraarticular injection of corticosteroids or hyaluronic acid in some joint during the 8 weeks of the study treatment.
9. The patient has received orally or intramuscularly, any corticosteroid, NSAID ns and / or COX-2s during the 14 days of the first dose of the study treatment.
10. The patient has a history of active peptic ulcer, active dyspepsia, gastrointestinal bleeding, esophageal, gastric and duodenal ulcer, during the three months prior to the evaluation of the
selection.
11. The patient has a history of clinically significant hypersensitivity to ns NSAIDs, COX-2s, analgesics or sulfa medications.
12. The patient has a known history of abuse of alcohol, analgesics, or narcotic substances during the month prior to the screening evaluation visit.
13. The patient has a history of some chronic condition not controlled, or some cognitive damage, which can make his participation in the study contraindicated, or confuse the interpretation of results.
14. The patient used analgesics and other agents during the four hours before treatment, which could confuse the analgesic responses.
15. For one year prior to the screening evaluation, the patient has been diagnosed with, or treated for or not in remission of, a cancer other than basal cell carcinoma.
16. The patient has received any investigational medication during the 30 days prior to the administration of the study medication or is scheduled to receive any investigational drug other than celecoxib, during the course of this study.
17. The patient has been previously admitted in this study.
18. Subjects with a history of a known ischemic heart disease, a peripheral arterial disease and / or cerebrovascular disease, as well as subjects with a previous procedure of coronary, carotid, cerebral, renal, aortic, or peripheral arterial revascularization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Visual analog scale (EVA): Consists of a horizontal line of 100 mm with a stop at the left end representing No pain and another at the far right, representing The Worst Pain possible. Patients will be asked to draw a vertical line on the horizontal scale at the point that best represents their current pain, by supporting their weight with the injured ankle.<br>Measure:Change from baseline to Day 3, from pain caused by ankle sprain.<br>Timepoints:Day 3.<br>
- Secondary Outcome Measures
Name Time Method