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

NCT02228616 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2017-09-15

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial · Xian-Janssen Pharmaceutical Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02228616 on ClinicalTrials.gov