Non-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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-001676-36-FI
• Date of registration: 04/10/2007
• Prospective Registration: Yes
• Primary sponsor: ORION PHARMA
• Public title: Non-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
• Scientific title: Non-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
• Date of first enrolment: 18/12/2007
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001676-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: Other:

Countries of recruitment

Finland

Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Constipation
MedDRA version: 9.1 Level: LLT Classification code 10010774 Term: Constipation

Intervention(s)

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 descriptive name: POTASSIUM CHLORIDE
CAS Number: 8000014439
Other descriptive name: MACROGOL 4000
Other descriptive name: SODIUM SULPHATE, ANHYDROUS
Other descriptive name: SODIUM HYDROGEN CARBONATE
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE

Primary Outcome(s)

Primary end point(s): To show non-inferiority of hypotpnic PEG product to isotonic PEG product.

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.

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 ID(s)

3066001