NCT02528201已完成4 期
A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 330
- 试验地点
- 27
- 主要终点
- Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12
研究概览
简要总结
A clinical trial to assess the effect of celecoxib 200 milligrams (mg) once daily and 400 milligrams (mg) once daily compared to diclofenac three times daily in the treatment of Ankylosing Spondylitis (AS) for 12 weeks. This will be used to confirm the results of a prior 6 week trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 75 years of age, inclusive.
- •Clinical diagnosis of ankylosing spondylitis:
- •Willing to stop existing NSAID/COX-2 inhibitor treatment for up to two weeks.
- •Having given written informed consent to participate in the trial.
- •Pain intensity ≥ 40 mm on the visual analog scale, worsening by at least 30 % compared to that recorded at the screening visit.
- •Last administration of analgesic without anti-inflammatory activity is ≥ 8 h, the last administration of long-acting NSAIDs is ≥ 72 h
排除标准
- •Patients with acute peripheral articular disease (defined by the onset within 4 weeks prior to visit
- •Known inflammatory enteropathy (e.g. ulcerative colitis, Crohn's disease).
- •Ongoing extra-articular signs (e.g. cardiac involvement).
- •Current painful vertebral compression.
- •Requirement to start physiotherapy, re-education or manipulation
- •History of clinical gastroduodenal ulcer in the year preceding inclusion, confirmed by endoscopy; continuing gastro-intestinal bleeding.
- •Cardiac failure or known renal insufficiency that could be affected by study medication, chronic or acute hepatic insufficiency, significant coagulation disorders or history of asthma.
- •Current or history of malignancy (except: patients having a basal cell carcinoma or other malignancy operated on and in remission for 5 years before inclusion in the trial).
- •Pregnancy, women of childbearing potential not using adequate contraceptive methods or nursing mothers.
- •Subject who has evidence of alcohol or drug abuse.
- •Participation in any other clinical study within 30 days prior to the screening visit.
- •Any condition that would prevent the patient from entering the study, according to the investigator's judgment.
- •Known hypersensitivity to celecoxib, sulphonamides or any NSAID (including salicylic acid).
- •Taking the following medications: Muscle relaxants, hypnotic, anxiolytics, sedatives, tranquillizers or antidepressants (unless stable for 2 weeks before screening and continuing throughout the trial), NSAIDs or COX-2 inhibitors other than study medication, acetylsalicylic acid (ASA) > 160 mg /day, anti-coagulants, ticlopidine, lithium, anti-TNF agents or methotrexate > 15 mg/week (Note: ASA ≤ 160 mg/day for cardioprotection is permitted), Use of oral or systemic analgesic medication, except from paracetamol, within 3 days of study entry and through the study, Corticosteroids (PO/IM/IV/IA) in the 6 weeks preceding inclusion in the trial, Anti-ulcer medication including chronic (daily or almost daily) use of antacids [Note: Occasional use of antacids during the study will be permitted.]
- •Change in dose of a slow-acting drug (e.g. sulfasalazin, methotrexate) in the past 60 days preceding inclusion in the trial.
- •Taking paracetamol > 2000 mg/day (including during the screening period).
研究组 & 干预措施
Celecoxib 200 milligrams mg QD
Active Comparator
celecoxib 200 milligrams (mg) once a day (QD)
干预措施: Celecoxib 200 milligrams (Drug)
Celexocib 400 mg QD
Active Comparator
celecoxib 400 milligrams (mg) once a day (QD)
干预措施: Celecoxib 400 milligrams (Drug)
Diclofenac 50 mg TID
Active Comparator
diclofenac 50 milligrams (mg) three times a day (TID)
干预措施: diclofenac 50 milligrams (Drug)
结局指标
主要结局
Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12
时间窗: Baseline, Week 12
Global Pain Intensity score (VAS): is a participant reported assessment of pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm= no pain and 100=most severe pain.
次要结局
- Participants Global Assessment of Pain Intensity (VAS)(Weeks 2, 6)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(Weeks 2, 6)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Weeks 2, 6)
- Participants and Physicians Global Assessment of Disease Activity(Weeks 2, 6, 12)
- Participants and Physicians Global Assessment of Treatment(Week 12)
- Participants Consumption of Rescue Medication(Baseline, Weeks 2, 6, 12)
研究者
研究点 (27)
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