Randomized, multicentre, single blind study to evaluate the effectiveness of two administration schedules of CitraFleet (sodium picosulfate plus magnesium citrate) to cleanse the colon

aboratorios Casen-Fleet S.L.U.0 个研究点目标入组 320 人开始时间: 2013年6月21日最近更新: 2014年3月17日

试验速览

暂无简介。

•1. Age: 18 years and older
•2. men or non-pregnant women.
•3. Subjects undergoing elective colonoscopy
•4. Subjects who, in the opinion of the Investigator, are able and willing to follow their assigned low-residue diet and hydration regimen
•5. Subjects who, in the opinion of the Investigator, are able and willing to comply with study requirements, with special emphasis on dosing instructions and diary completion.
•6. Subjects who have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
•7. Subjects who have hand-signed and dated their informed consent form
•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 260
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1. Congestive heart failure or decompensated heart insufficiency
•2. Gastrointestinal conditions contraindicating the administration of CitraFleet: nausea and vomiting, gastric retention, gastro-intestinal ulceration, ileus, toxic colitis, toxic megacolon, gastro-intestinal obstruction or perforation, active inflammatory bowel disease
•3. Ascites
•4. Acute surgical abdominal conditions such as acute appendicitis
•5. Severe dehydration
•6. Hypermagnesaemia
•7. Rhabdomyolysis
•8. Hypersensitivity to any of the ingredients of the IP
•9. Ingestion of an investigational product within 1 month prior to screening
•10. Severe chronic kidney disease (ie, stage >3 chronic kidney disease [CKD])
•11. Have, in the opinion of the investigator, any condition that may make them unsuitable for inclusion in the study

发起方

aboratorios Casen-Fleet S.L.U.