Constipation Clinical Trial
Official title:
A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation
The primary objective of the study was to evaluate the proportion of subjects with a bowel
movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of
treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus
Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses
of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported
BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM
control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.
In addition, the proportion of subjects with a BM (without straining and without hard and/or
lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E
was evaluated for the time to first BM.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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