drugset / Trial / NCT02228616

Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation

NCT02228616

Phase 4 Completed 280 enrolled Xian-Janssen Pharmaceutical Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally once daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the percentage of subjects with a weekly average increase of 1 or more spontaneous complete bowel movements (SCBMs) (responders) during the 12-week treatment phase as compared to the baseline.

Timeline

Start
2014-10-14
Primary completion
2016-09-28
Completion
2016-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Prucalopride Small molecule 2 mg Oral
Background Lactulose Other / unclassified
Background polyethylene glycol Other / unclassified

Indications