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 sitesOctober 4, 2007

Overview

No summary available.

Registry

who.int

Start Date

October 4, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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