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Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation

Constipation Clinical Trial

Official title:
Double-dummy, Double-blind, Randomised, Parallel Group, Controlled Comparative Study of Polyethylene Glycol (PEG)Plus Electrolytes Versus Prucalopride in Females With Chronic Constipation Who Failed Adequate Relief With Laxatives

Clinical Trial Summary

This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that of prucalopride in the treatment of chronic constipation in females. A total of 240 patients will be randomly allocated to treatment with one or the other agent. The study consists of a 14-day run-in period, with treatment subsequently administered for 28 days on a daily basis. During the study, patients will fill in a stool diary, samples of faeces will be collected, and colonic transit time will be measured prior to therapy, and from days 22 to 28 of treatment. The proportion of patients with normalised bowel movements (three or more spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will be compared between treatments.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01251822
Study type Interventional
Source Norgine
Contact
Status Completed
Phase Phase 3
Start date November 2010
Completion date December 2011
View Details
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