Constipation Clinical Trial
Official title:
Evaluation of Oral Tolerance MiraLAX Solution Concentrate in Subjects With Chronic Constipation
The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG 3350 solution concentrate to oral ingestion of a placebo solution concentrate, in participants with constipation.
This was a randomized, single-blind, placebo-controlled study to evaluate the proportion of participants with abnormalities of the oral mucosa detected by visual examination of the oral cavity in the polyethylene glycol (PEG) 3350 group compared with the placebo group. The study was also to evaluate the proportion of participants with abnormalities of the esophageal mucosa detected by endoscopic examination of the esophagus in the PEG 3350 group compared with the placebo group, and to compare the safety and tolerability by evaluation of the proportion of participants with the occurrence of adverse events (AEs) or adverse drug reactions. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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