NCT00603681

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-01-29
• Last updated: 2008-10-07

Locations

10 sites across 1 country: Finland