EUCTR2007-005912-23-IT进行中（未招募）不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, ACTIVE-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CELECOXIB (CELEBREX) AND INDOMETHACIN IN THE TREATMENT OF MODERATE TO SEVERE ACUTE GOUTY ARTHRITIS - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; 2. At least 18 years of age or older; 3. Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout (See Appendix 1); 4. Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1); 5. A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient?s Assessment of Pain Intensity in the Index Joint (5-point scale: 0-4) at Screening/Baseline; 6. Candidate for daily therapy with an NSAID and/or analgesic, in the investigator?s judgment; 7. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; 8. If the patient is female and of childbearing potential, she must be using adequate contraception since her last menses, continue using adequate contraception during the study, not lactating, and must have had a negative urine pregnancy test confirmed at Screening/Baseline. (Note: Women who are post-menopausal or are surgically sterilized for less than 2 years, will also require a urine pregnancy test at Screening/Baseline).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of any other type of arthritis including those types suspected of being infectious in origin or presence of any acute trauma in the Index Joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator?s criteria) and it does not affect the Index Joint; 2. Acute polyarticular gout (involving greater than 4 joints) or chronic gout; 3. Use of any NSAID or analgesic therapy to treat the current acute gouty arthritis attack; 4. Patients on any of the following medications are specifically excluded: Chronic NSAID and/or analgesic therapy (defined as >1 week) within 5 half lives (for the particular agent) prior to Screening/Baseline (See Appendix 3); Acetylsalicylic acid (ASA) at doses of >325 mg/day. Patients taking 1.2 mg daily. Patients taking a stable daily dose 1.5 × the upper limit of the reference range, creatinine >1.5 mg/dL, or any other laboratory abnormality that in the opinion of the investigator would contraindicate study participation. Results from the analyses of complete blood count (CBC), blood chemistries, and/or urinalysis obtained within 6 months prior to Screening/Baseline must be available for determination of eligibility; 8. History of known alcohol or other substance abuse (in the investigator?s opinion) within 2 years of Screening/Baseline; 9. Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 60 days prior to Screening/Baseline;
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