Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Prucalopride; Polyethylene glycol (PEG); Lactulose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; Optimized dose of PEG will be administrated for 13 weeks (1 week run-in+12 weeks intervention).; Optimized dose of Lactulose will be administrated for 13 weeks (1 week run-in+12 weeks intervention).
Intervention MeSH terms: Lactulose; Prucalopride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Constipation; Chronic constipation; Prucalopride; Women