NCT02228616

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

A Multicenter, Single-Arm, Interventional, Phase 4 Study to Evaluate the Efficacy and Safety of Prucalopride in Combination With PEG or Lactulose in Women With Chronic Constipation (CC)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, open-labeled, single-arm, interventional study to evaluate the efficacy and safety of prucalopride in real clinical practice. It consists of 2 phases: a 1-week run-in phase, a 12 week, open-label treatment phase. Study population is women with CC who have been treated with laxatives but failed to obtain adequate relief within the preceding 6 months. Patients who meet the inclusive and without exclusive criteria will be enrolled in the study and signed an Informed Consent Form. They are instructed not to change their diet, lifestyle during the study. At the first week of the study, subjects will continue PEG or lactulose treatment, and they will not be allowed to use any other laxatives and drugs for CC. Subjects will be required to maintain a written stool diary as well as the use of PEG and lactulose. Any drug affecting the colonic motility will be prohibited during the study. Following this run-in phase, subjects enter the 12-week open-label treatment phase. During the treatment phase, subjects will be treated for 12 weeks with prucalopride 2 mg, given orally once daily with or without breakfast in the morning. Subjects will be required to continue PEG or lactulose treatment with the same dosage as that in the run-in period. If necessary, due to intolerable side effects (ie, severe diarrhea,), dosage decrements of PEG or lactulose treatment may be made at any time or the subject could discontinue the PEG or lactulose treatment, based on investigator's judgement. Subjects will record study drug and laxative medication dosing information and information related to BMs in a daily diary throughout the study. PAC-SYM and PAC QOL questionnaires will be completed at Weeks 0, 4, 12. Subject safety will be monitored throughout the study.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Prucalopride	During the 12-week treatment phase of the study, the daily dose of 1 tablet of 2-mg prucalopride will be administrated orally before breakfast.
DRUG	Polyethylene glycol (PEG)	Optimized dose of PEG will be administrated for 13 weeks (1 week run-in+12 weeks intervention).
DRUG	Lactulose	Optimized dose of Lactulose will be administrated for 13 weeks (1 week run-in+12 weeks intervention).

Timeline

• Start date: 2014-10-14
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2014-08-29
• Last updated: 2017-09-15

Locations

9 sites across 1 country: China