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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Polyethylene glycol 4000
Polyethylene glycol 4000 with electrolytes
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, aged, polyethylene glycol

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Koskikoti
  • Koivupirtti
  • Tampereen sotainvalidien Veljeskoti
  • Lahdensivun koti
  • Nurmikoti
  • Vire Koti Kaukaharju assisted-living facility
  • Taatala assested-living facility
  • Kuusela assisted-living facility
  • Petäjäkoti
  • Nursing home of Tiuravuori

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T

C

Arm Description

Test product

Reference product

Outcomes

Primary Outcome Measures

Stool frequency

Secondary Outcome Measures

Stool frequency
Stool straining
Stool consistency

Full Information

First Posted
January 16, 2008
Last Updated
October 6, 2008
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00603681
Brief Title
Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation
Acronym
PEGorion
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

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, aged, polyethylene glycol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T
Arm Type
Experimental
Arm Description
Test product
Arm Title
C
Arm Type
Active Comparator
Arm Description
Reference product
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol 4000
Other Intervention Name(s)
Pegorion
Intervention Description
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
Intervention Name(s)
Polyethylene glycol 4000 with electrolytes
Other Intervention Name(s)
Colonsoft
Intervention Description
granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
Primary Outcome Measure Information:
Title
Stool frequency
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Stool frequency
Time Frame
Week 2
Title
Stool straining
Time Frame
Weeks 2 and 4
Title
Stool consistency
Time Frame
Weeks 2 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauri Seinelä, MD
Organizational Affiliation
Pirkanmaan erikoislääkäripalvelu Oy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulla Sairanen, MSc
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Koskikoti
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Koivupirtti
City
Tampere
ZIP/Postal Code
33500
Country
Finland
Facility Name
Tampereen sotainvalidien Veljeskoti
City
Tampere
ZIP/Postal Code
33500
Country
Finland
Facility Name
Lahdensivun koti
City
Tampere
ZIP/Postal Code
33560
Country
Finland
Facility Name
Nurmikoti
City
Tampere
ZIP/Postal Code
33680
Country
Finland
Facility Name
Vire Koti Kaukaharju assisted-living facility
City
Tampere
ZIP/Postal Code
33710
Country
Finland
Facility Name
Taatala assested-living facility
City
Tampere
ZIP/Postal Code
33820
Country
Finland
Facility Name
Kuusela assisted-living facility
City
Tampere
ZIP/Postal Code
33900
Country
Finland
Facility Name
Petäjäkoti
City
Tampere
ZIP/Postal Code
33900
Country
Finland
Facility Name
Nursing home of Tiuravuori
City
Ylöjärvi
ZIP/Postal Code
33480
Country
Finland

12. IPD Sharing Statement

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

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