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

Constipation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603681
• Other study ID #: 3066001
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2008
• Last updated: October 6, 2008
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: October 2008
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Constipation

Intervention

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
• 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

Locations

Country	Name	City	State
Finland	Koivupirtti	Tampere
Finland	Koskikoti	Tampere
Finland	Kuusela assisted-living facility	Tampere
Finland	Lahdensivun koti	Tampere
Finland	Nurmikoti	Tampere
Finland	Petäjäkoti	Tampere
Finland	Taatala assested-living facility	Tampere
Finland	Tampereen sotainvalidien Veljeskoti	Tampere
Finland	Vire Koti Kaukaharju assisted-living facility	Tampere
Finland	Nursing home of Tiuravuori	Ylöjärvi

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool frequency		week 4	No
Secondary	Stool frequency		Week 2	No
Secondary	Stool straining		Weeks 2 and 4	No
Secondary	Stool consistency		Weeks 2 and 4	No