Constipation MedDRA version: 9.1 Level: LLT Classification code 10010774 Term: Constipation
Conditions
Interventions
Trade Name: Pegorion
Pharmaceutical Form: Oral solution
CAS Number: 8000014439
Other descriptive name: MACROGOL 4000
Trade Name: Colonsoft
Pharmaceutical Form: Oral solution
CAS Number: 7447407
Other
Sponsors
ORION PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Finland
Outcome results
None listed