Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.