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

PHASE4CompletedINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

October 14, 2014

Primary Completion Date

September 28, 2016

Study Completion Date

September 28, 2016

Conditions
Constipation
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).

Trial Locations (9)

Unknown

Beijing

Binzhou

Chongqing

Hangzhou

Nanjing

Shanghai

Tianjin

Wuhan

Zhengzhou

All Listed Sponsors
lead

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

NCT02228616 - Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation | Biotech Hunter | Biotech Hunter