Clinical trial NCT00603681: Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Keywords: constipation
aged
polyethylene glycol
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 67
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stool frequency
timeFrame: week 4
Secondary outcomes:
measure: Stool frequency
timeFrame: Week 2
measure: Stool straining
timeFrame: Weeks 2 and 4
measure: Stool consistency
timeFrame: Weeks 2 and 4
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Koskikoti
city: Tampere
country: Finland
facility: Koivupirtti
city: Tampere
country: Finland
facility: Tampereen sotainvalidien Veljeskoti
city: Tampere
country: Finland
facility: Lahdensivun koti
city: Tampere
country: Finland
facility: Nurmikoti
city: Tampere
country: Finland
facility: Vire Koti Kaukaharju assisted-living facility
city: Tampere
country: Finland
facility: Taatala assested-living facility
city: Tampere
country: Finland
facility: Kuusela assisted-living facility
city: Tampere
country: Finland
facility: Petäjäkoti
city: Ylöjärvi
country: Finland
facility: Nursing home of Tiuravuori
Study officials:
affiliation: Pirkanmaan erikoislääkäripalvelu Oy
name: Lauri Seinelä, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orion Corporation, Orion Pharma
name: Ulla Sairanen, MSc
role: STUDY_DIRECTOR
References: