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 - Pegorio

Conditions: Constipation
MedDRA version: 9.1Level: LLTClassification code 10010774Term: Constipation

Registration Number: EUCTR2007-001676-36-FI

Lead Sponsor: ORION PHARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to show non-inferiority of hypotonic PEG product to isotonic PEG product in efficacy in elderly institutionalised patients. The other main objective is to demonstrate that hypotonic PEG product is safe and well tolerated.;Secondary Objective: Secondary objective is to compare the taste and willingness to use either hypotonic or isotonic PEG products. This will be done by interviewing the study subjects at the end of the study and by giving them the opportunity to compare the products.;Primary end point(s): To show non-inferiority of hypotpnic PEG product to isotonic PEG product.

Secondary Outcome Measures