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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00603681

Acronym

PEGorion

Enrollment

Registered

2008-01-29

Start date

2008-01-31

Completion date

2008-07-31

Last updated

2008-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

constipation, aged, polyethylene glycol

Brief summary

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

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.

Interventions

DRUGPolyethylene glycol 4000

powder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks

DRUGPolyethylene glycol 4000 with electrolytes

granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Stool frequency	week 4

Secondary

Measure	Time frame
Stool frequency	Week 2
Stool straining	Weeks 2 and 4
Stool consistency	Weeks 2 and 4

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026