Celebrex In Acute Gouty Arthritis Study
- Conditions
- -M10M10
- Registration Number
- PER-062-08
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• Have provided written, signed and dated informed consent stating that the patient has been informed of all relevant aspects of the study.
• Be at least 18 years of age or older;
• Acute gouty arthritis that meets the criteria of the American College of Rheumatology (ACR) for acute arthritis of primary gout (see Appendix 1);
• Start of pain of an attack of acute gouty arthritis within 48 hours before the Selection / Baseline (Visit 1);
• A classification of moderate, severe or extreme (2, 3 or 4, respectively) in the Pain Intensity Assessment performed by the Patient in the reference joint during the previous 24 hours (scale of 5 points: 0-4) in the Selection / Baseline;
• The patient must be a candidate for daily therapy with NSAIDs and / or analgesics, in the opinion of the researcher;
• Patients must be willing to comply with the schedule of visits, treatment plan, laboratory tests and any other procedure;
• Women with the ability to conceive should be using an adequate contraceptive method since their last menstruation, and continue using that method during the study. In addition, women should not be breastfeeding a baby, and they should have had a negative pregnancy test in urine confirmed in Basal. (Note: Women who have been postmenopausal or surgically sterilized for a period of <2 years must undergo a pregnancy test on the Baseline).
• Diagnosis of any other type of arthritis, including those types that are suspected to be of infectious origin in the reference joint, or the presence of any acute trauma of the reference joint;
• Acute polyarticular drop that involves more than 4 joints, or chronic tophaceous gout;
• Use of any therapy with NSAIDs or analgesics to treat the current attack of gouty arthritis;
• History of acute or chronic gouty arthritis that has not responded to NSAIDs;
• Any significant, uncontrolled chronic disease, including psychiatric disorders or cognitive impairment, or any other condition that, in the opinion of the investigator, is a contraindication to participation in the study or may cause confusion in the interpretation of the results;
• Known laboratory abnormalities, including AST, ALT or blood urea nitrogen (NUS)> 1.5 x the maximum limit of the reference range, creatinine> 1.5 mg / dL (132.6 pmol / L), or any other laboratory abnormality that, in opinion of the researcher, constitutes a contraindication for participation in the study. The results of the analysis of the complete blood count (CBC), blood chemistry and urinalysis obtained within 6 months prior to the Baseline Selection / Line must be available for the determination of eligibility;
• History of known abuse of alcohol or other substances (in the opinion of the investigator) in the 2 years prior to the Selection / Baseline;
• Diagnosis of esophageal, gastric ulceration of the pyloric or duodenal canal, or having been treated for these conditions within 60 days prior to the Selection / Baseline;
• Known hypersensitivity, allergy or hypersensitivity to sulfonamides, selective inhibitors of COX-2 (including celecoxib), acetylsalicylic acid or NSAIDs (including indomethacin). Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs should be excluded;
• Active GI disease (eg, inflammatory bowel disease, Crohn´s disease, ulcerative colitis, gastroesophageal reflux disease), a chronic or acute renal or hepatic disorder, a significant clotting defect, or any condition that, in the opinion of the researcher, may prevent the use of an NSAID (eg, congestive heart failure);
• Active malignancy of any kind, including suspicion of metastasis or treatment for cancer (ie surgery, chemotherapy, radiation therapy, etc.), or remission of any cancer other than basal cell carcinoma for less than 2 years before of the Selection / Baseline;
• The patient has symptoms, signs, or is receiving treatment, for congestive heart failure (NYHA H-IV Classification), or has known left ventricular dysfunction with an ejection fraction <40%
• The patient has a history of myocardial infarction or cerebrovascular accident (cerebrovascular event) in the 6 months prior to the Selection / Baseline;
• The patient has planned revascularization (percutaneous coronary intervention [PCI] or coronary bypass surgery [CPC]) at the time of Selection / Baseline,
• The patient has an unstable condition,
• Patients who are known or suspected of having a poor metabolism for CYP2C9 based on their previous history or experiences with some other CYP2C9 substrate;
• Probability of not complying with the study procedures;
• Previous participation in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method