A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
2015年8月18日 更新者：Pfizer
A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis
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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
330
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bekkestua、挪威、1357
- Bekkestua legesenter
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Bergen、挪威、5004
- Dr. Johannessen Kontor
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Bergen、挪威、5838
- Dr.Wiigs kontor
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Bodø、挪威、8006
- Nordland Medisinske Senter
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Bærum Postterminal、挪威、1306
- Martina Hansens Hospital
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Drammen、挪威、3004
- Sykehuset Buskerud HF
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Gamle Fredrikstad、挪威、1632
- Lægene på Kongens torv
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Hamar、挪威、2300
- Centre For Clinical Trials
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Harstad、挪威、9480
- Harstad sykehus
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Haugesund、挪威、5513
- Haugesund sanitetsforenings revmatismesykehus
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Horten、挪威、3188
- Horten legesenter
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Jessheim、挪威、2050
- Solli Klinikk AS
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Kongsvinger、挪威、2226
- Kongsvinger sykehus HF
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Kristiansand、挪威、4604
- Vest-Agder sentralsykehus
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Kristiansand、挪威、4610
- Dr. Svensens kontor
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Lena、挪威、2850
- Lensbygda Legekontor
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Levanger、挪威、7600
- Helse Nord-Trøndelag HF, Sykehuset Levanger
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Lillehammer、挪威、2609
- LSF Reumatismesykehus
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Mo I Rana、挪威、8607
- Helgelandssykehuset HF
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Oslo、挪威、0027
- Rikshospitalet
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Oslo、挪威、0580
- Økernlegene
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Oslo、挪威、N-0319
- Diakonhjemmet Hospital
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Skien、挪威、3722
- Betanien Hospital
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Tiller、挪威、7092
- Rosten legesenter
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Tromsø、挪威、9038
- Universitetssykehuset Nord-Norge HF
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Trondheim、挪威、7006
- St.Olavs Hospital
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Ålesund、挪威、6026
- Ålesund Sykehus
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Celecoxib 200 milligrams mg QD
celecoxib 200 milligrams (mg) once a day (QD)
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Celecoxib 200 milligrams once a day
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有源比较器：Celexocib 400 mg QD
celecoxib 400 milligrams (mg) once a day (QD)
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Celecoxib 400 milligrams once a day
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有源比较器：Diclofenac 50 mg TID
diclofenac 50 milligrams (mg) three times a day (TID)
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diclofenac 50 milligrams three times a day
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12
大体时间：Baseline, Week 12
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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.
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Baseline, Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participants Global Assessment of Pain Intensity (VAS)
大体时间：Weeks 2, 6
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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.
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Weeks 2, 6
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Bath Ankylosing Spondylitis Functional Index (BASFI)
大体时间：Weeks 2, 6
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BASFI is a validated self assessment tool that determines the degree of functional limitation in AS.
Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities.
The BASFI score is a mean score of the 10 questions.
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Weeks 2, 6
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
大体时间：Weeks 2, 6
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BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS).
Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue.
The final BASDAI score averages the individual assessments for a final score range of 0-10
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Weeks 2, 6
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Participants and Physicians Global Assessment of Disease Activity
大体时间：Weeks 2, 6, 12
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Participants are asked at each visit the following questions: Taking everything into account how do you assess the activity of your disease in the last 2 days on a scale where: 0=disease inactive with no symptoms and 100=disease extremely active?
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Weeks 2, 6, 12
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Participants and Physicians Global Assessment of Treatment
大体时间：Week 12
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The patients will be asked up to four global questions about safety and efficacy of the trial medication and about their current disease status.
Responses are done on a 5 point scale where 0=no effect, 1=poor effect, 2=moderate effect, 3=good effect, and 4=excellent.
At the same visits the investigator will be asked to do his/her own judgment of the efficacy and tolerance of the treatment (excellent, good, moderate, poor).
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Week 12
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Participants Consumption of Rescue Medication
大体时间：Baseline, Weeks 2, 6, 12
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Participant consumption of rescue medication (paracetamol) calculated at each individual visit (except from the screening visit) by counting returned tablets versus tablets dispensed at the previous visit.
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Baseline, Weeks 2, 6, 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年9月1日
初级完成 (实际的)
2004年11月1日
研究完成 (实际的)
2004年11月1日
研究注册日期
首次提交
2015年6月18日
首先提交符合 QC 标准的
2015年8月18日
首次发布 (估计)
2015年8月19日
研究记录更新
最后更新发布 (估计)
2015年8月19日
上次提交的符合 QC 标准的更新
2015年8月18日
最后验证
2015年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.