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Completed

NCT Number: NCT00603681

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Koivupirtti, Tampere, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene glycol 4000

Drug

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

Other names: Pegorion

Polyethylene glycol 4000 with electrolytes

Drug

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

Other names: Colonsoft

Primary outcomes

  1. Stool frequency

    Time frame: week 4

Secondary outcomes

  1. Stool frequency

    Time frame: Week 2

  2. Stool straining

    Time frame: Weeks 2 and 4

  3. Stool consistency

    Time frame: Weeks 2 and 4

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study 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, Parallel-Group, Multicentre Study

Acronym: PEGorion

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 29, 2008
Registry last updated
Oct 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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