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