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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00603681
First received: January 16, 2008
Last updated: October 6, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Constipation
 Drug: Polyethylene glycol 4000
Drug: Polyethylene glycol 4000 with electrolytes
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Stool frequency [ Time Frame: week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stool frequency [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Stool straining [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
  • Stool consistency [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T
Test product
 Drug: 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
Other Name: Pegorion
Active Comparator: C
Reference product
 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
Other Name: Colonsoft

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603681

Locations
Finland
Koskikoti
Tampere, Finland, 33100
Lahdensivun koti
Tampere, Finland, 33560
Nurmikoti
Tampere, Finland, 33680
Petäjäkoti
Tampere, Finland, 33900
Taatala assested-living facility
Tampere, Finland, 33820
Vire Koti Kaukaharju assisted-living facility
Tampere, Finland, 33710
Koivupirtti
Tampere, Finland, 33500
Kuusela assisted-living facility
Tampere, Finland, 33900
Tampereen sotainvalidien Veljeskoti
Tampere, Finland, 33500
Nursing home of Tiuravuori
Ylöjärvi, Finland, 33480
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Lauri Seinelä, MD Pirkanmaan erikoislääkäripalvelu Oy
Study Director: Ulla Sairanen, MSc Orion Corporation, Orion Pharma
  More Information

No publications provided

Responsible Party: Ulla Sairanen, Orion Pharma
ClinicalTrials.gov Identifier: NCT00603681     History of Changes
Other Study ID Numbers: 3066001
Study First Received: January 16, 2008
Last Updated: October 6, 2008
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Orion Corporation, Orion Pharma:
constipation
aged
polyethylene glycol

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013