NCT01335386已完成2 期
Efficacy and Safety of KLYX Versus Glycerine Enema in Chinese Patients With Constipation - a Randomised, Assessor-blind Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Overall efficacy of enema
研究概览
简要总结
This is a randomised, assessor-blind, multi-centre pilot study to investigate the comparative safety and efficacy of KLYX and glycerine enema in the symptomatic treatment of constipation in Chinese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
- •Ethnically Chinese
- •Males or females aged between 18 and 65 years inclusive
- •A history of constipation symptoms for at least 6 months fulfilling, with occurrence of two or more of the following symptoms during the 3 months before screening (the 3 months need not be consecutive):
- •i. Very hard (pellet-like) and/or hard stools (Type 1 or 2 of the Bristol Stool Scale) for at least 25% of the time; or ii. Sensation of incomplete evacuation at least 25% of the time; or iii. Straining during defecation at least 25% of the time; or iv. Sensation of anorectal obstruction or blockage often during defecation at least 25% of the time; or v. Manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation, support of the pelvic floor) at least 25% of the time; or vi. Fewer than 3 defecations per week.
- •Patient has had no bowel movement (i.e. still constipated) two days prior randomisation.
排除标准
- •Any disorder or laboratory result at Screening that in the judgement of the investigator that will place the subject at excessive risk if participating in a controlled study
- •Clinically suspected to have colorectal cancer
- •Significant gastroparesis or gastric outlet obstruction
- •Hypersensitivity to sodium docusate and/or sorbitol
- •Hypersensitivity to glycerine
- •Pregnant or lactating women, women who intend to conceive, or women who are sexually active and capable of pregnancy who are not using a method of birth control (e.g. prescription hormonal contraceptives, intrauterine device, double-barrier method, male partner sterilization)
- •Diabetic patients currently on insulin therapy
- •Having participated in other clinical trial(s) within the 3 (three) months prior screening
- •Unable to withdraw medications that may affect gastrointestinal motility such as prokinetics, erythromycin analogues, laxatives, etc.
- •Unable to meet or perform study requirements: known or suspected inability to comply with the study protocol
研究组 & 干预措施
KLYX
Experimental
干预措施: KLYX (Drug)
Glycerine
Active Comparator
干预措施: Glycerine (Drug)
结局指标
主要结局
Overall efficacy of enema
时间窗: immediately following enema administration
次要结局
- Time to first bowel movement(Immediately following enema administration)
- Patient's overall satisfaction with enema treatment(Immediately following enema administration)
- Stool form after enema treatment(Immediately following enema administration)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial SurgeryCerebrospinal Fluid LeakNCT04086550Polyganics BV228
撤回
早期 1 期
Treatment of Melasma With Glycolic Acid-Salicylic Acid Peel Versus Glycolic Acid PeelMelasmaNCT02812719Boston Medical Center
尚未招募
4 期
Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic RetinopathyDiabetic Kidney DiseaseDiabetic RetinopathyNCT06660940Chinese PLA General Hospital460
已完成
2 期
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus BacteremiaStaphylococcus Aureus BacteremiaStaphylococcus Aureus EndocarditisNCT03163446ContraFect121
Unknown
2 期
Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic PainDiabetic PolyneuropathyPostherpetic NeuralgiaPeripheral NeuropathyNCT02597257Seoul National University Hospital44