ACTRN12612000536864撤回3 期
Endocrine and metabolic effects of non steroidal anti-inflammatory therapy in overweight, hypogonadal men with obstructive sleep apnea: A pilot study
Woolcock0 个研究点目标入组 20 人开始时间: 2012年5月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Male
入选标准
- •1.Males aged 18-65 with obstructive sleep apnea with respiratory disturbance Index (RDI) greater than or equal to 5/hr
- •2.Overweight or obese (BMI > 27 kg.m-2)
- •3.Hypogonadism (T < 10 nmol/L) measured on two occasions
- •4.Waitlisted for CPAP-therapy or treatment refusers
- •5.Medical history, physical examination and laboratory screening indicating no clinical or laboratory evidence for significant and uncontrolled cardiovascular (ischemic, hypertension), renal, liver disease (serum electrolytes, urea and creatinine, liver function tests and full blood count).
排除标准
- •3.Patients currently receiving CPAP-therapy
- •4.Severe OSA requiring immediate treatment due to severity or increased associated risk (eg Transport worker)
- •5.Significant and uncontrolled cardiovascular (ischemic heart disease, Congestive heart failure (NYHA II-IV), , hypertension, stroke), renal, liver disease as determined by medical history, physical examination and laboratory screening indicating clinical or laboratory evidence.
- •6.Doctor diagnosed diabetes.
- •7. Known hypersensitivity to celecoxib or any of the excipients contained in the celeboxib capsules (lactose, sodium lauryl sulfate, povidine, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, iron yellow oxide, indigo carmine).
- •8.Demonstrated allergic-type reactions to sulfonamides.
- •9.Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs, including other COX-2 specific inhibitors.
- •10.Patients using other non-steroidal anti-inflammatory drugs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions (excluding low dose < 150 mg daily aspirin).
- •11.Active peptic ulceration or gastrointestinal (GI) bleeding.
- •12.Patients with estimated creatinine clearance <30 mL/min.
- •13.Severe hepatic impairment (Child-Pugh score 10- classifies the severity of liver disease)
- •14.Perioperative CABG surgery, unstable (thrombus aetiology), significant IHD, peripheral artery, cerebrovascular disease
- •15.Drug and alcohol abuse/dependence
- •16. Shift workers or patients with an irregular sleep / wake routine.
- •17. Current smokers
- •18. Current infection
- •19. Any chronic medical conditions likely, in the judgment of the investigator, that makes the patient unable to complete the study safely, or otherwise unsuitable for the study or that may interfere with or influence study treatment.
研究者
相似试验
招募中
4 期
The neuroendocrine and metabolic effects of oestrogenseuroendocrine regulation of GH secretion by oestrogensMetabolic effects of oestrogensNeuroendocrine regulation of GH secretion by oestrogensMetabolic and Endocrine - Normal metabolism and endocrine development and functionACTRN12611001093976Garvan Institute of Medical Research20
已完成
不适用
The metabolic effects of endocrine therapy in postmenopausal women with oestrogen-receptor-positive breast canceroestradiol depletionCardiovascular - Coronary heart diseaseMetabolic and Endocrine - Metabolic disordersCancer - BreastBreast cancerMenopausecardiovascular diseaseACTRN12619001046190The Department of Medicine, Austin Hospital105
招募中
2 期
To compare the efficacy of metformin versus metformin plus myoinositol in infertile PCOS women undergoing ovulation induction plus intrauterine insemination.CTRI/2017/07/009021AIIMS80
已完成
不适用
se of insulin sensitisers to revert metabolic syndromeISRCTN58810841Hospital Sant Joan de Deu (Spain)52
招募中
不适用
De invloed van gelijktijdig gebruik van NSAIDs en andere MRP-4 remmers op de nieren bij HIV patiënten die worden behandeld met TDF bevattend antiretroviraal regiems. De NSHIV studie.Renal dysfunctionproximal tubulopathyHIV-1NL-OMON21361Erasmus Medical Center Rotterdam, the Netherlands.600