drugset / Trial / NCT02228616
Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prucalopride | Small molecule | 2 mg | Oral |
| Background | Lactulose | Other / unclassified | — | — |
| Background | polyethylene glycol | Other / unclassified | — | — |