Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation

Study Overview
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Brief Summary
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The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined.

Detailed Description
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Constipation is a major problem in elderly institutionalised patients. Non-pharmacological treatments are proposed as primary management of constipation, but institutionalised patients are not likely to be able to increase either the intake of dietary fibre or fluid and their physical activity is low. The latest agent widely used for the treatment of constipation is polyethylene glycol (PEG). PEG is classified into the group of osmotic laxatives. It is minimally absorbed from the gastrointestinal tract and not metabolised by colonic bacteria. Most of the PEG products at the market contain electrolytes and have a salty and unpleasant taste which may affect the compliance of using them. A PEG solution without electrolytes has been developed and used for some years in various countries. Now we will compare the efficacy and safety of PEG solutions with or without electrolytes and their acceptability in the use for constipation in institutionalised patients.

Official Title
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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, Parallel-Group, Multicentre Study

Conditions
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Constipation

Intervention / Treatment
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* Drug: Polyethylene glycol 4000
* Drug: Polyethylene glycol 4000 with electrolytes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isotonic PEG treatment for constipation at the stable dose for at least 2 weeks before the run-in period Exclusion Criteria: Other medical treatment for constipation than isotonic PEG or plantago ovata seeds Severe dementia

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T<br>Test product | Drug: Polyethylene glycol 4000<br>* powder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks<br>* Other names: Pegorion;|
| Active Comparator: C<br>Reference product | Drug: Polyethylene glycol 4000 with electrolytes<br>* granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks<br>* Other names: Colonsoft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency |  | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency |  | Week 2 | 
| Stool straining |  | Weeks 2 and 4 | 
| Stool consistency |  | Weeks 2 and 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, aged, polyethylene glycol