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

NCT ID: NCT00603681

Last Updated: 2008-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-07-31

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.

Conditions

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Constipation

Keywords

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constipation aged polyethylene glycol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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T

Test product

Group Type EXPERIMENTAL

Polyethylene glycol 4000

Intervention Type DRUG

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

C

Reference product

Group Type ACTIVE_COMPARATOR

Polyethylene glycol 4000 with electrolytes

Intervention Type DRUG

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

Interventions

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Polyethylene glycol 4000

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

Intervention Type DRUG

Polyethylene 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

Intervention Type DRUG

Other Intervention Names

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Pegorion Colonsoft

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Orion Pharma

Principal Investigators

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Lauri Seinelä, MD

Role: PRINCIPAL_INVESTIGATOR

Pirkanmaan erikoislääkäripalvelu Oy

Ulla Sairanen, MSc

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

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Koskikoti

Tampere, , Finland

Site Status

Koivupirtti

Tampere, , Finland

Site Status

Tampereen sotainvalidien Veljeskoti

Tampere, , Finland

Site Status

Lahdensivun koti

Tampere, , Finland

Site Status

Nurmikoti

Tampere, , Finland

Site Status

Vire Koti Kaukaharju assisted-living facility

Tampere, , Finland

Site Status

Taatala assested-living facility

Tampere, , Finland

Site Status

Kuusela assisted-living facility

Tampere, , Finland

Site Status

Petäjäkoti

Tampere, , Finland

Site Status

Nursing home of Tiuravuori

Ylöjärvi, , Finland

Site Status

Countries

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Finland

Other Identifiers

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3066001

Identifier Type: -

Identifier Source: org_study_id