on-inferiority study; Comparison of polyethylene glycol solution with and without electrolytes for treatment of chronic constipation in elderly institutionalised patients: a double-blind, randomised, parallelgroup,multicentre study - Pegorion

ORION PHARMA0 个研究点开始时间: 2007年10月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Written informed consent obtained
•2. Isotonic PEG treatment for constipation at a stable dose with no other medication used for constipation (except plantago ovata seeds) for at least 2 weeks before the run-in period.
•3. Stool frequency at least 3 per week during the last 2 weeks before the run-in period
•4. Having been institutionalised for at least 4 weeks and likely to be institutionalised for the duration of the study
•5. Age 65 years or above
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Severe dementia
•2. Acute gastrointestinal obstruction, gastric retention or perforation
•3. Toxic or active colitis
•4. Allergy to PEG
•5. Lack of co-operation due a psychiatric illness
•6. Acute disease according to the investigator’s judgment
•7. Current or recent (1 month) participation in another clinical drug study
•8. Other medical treatment of constipation than laxatives containing isotonic PEG or plantago ovata seeds

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