A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation.
Phase of Trial: Phase IV
Latest Information Update: 05 Mar 2018
At a glance
- Drugs Prucalopride (Primary)
- Indications Constipation
- Focus Therapeutic Use
- Sponsors Shire-Movetis NV
- 05 Mar 2018 The U.S. Food and Drug Administration (FDA) has accepted the submission of a New Drug Application (NDA) for prucalopride (also known as SHP555) for chronic idiopathic constipation (CIC) in adults. The FDA is expected to provide a decision on or around December 21, 2018, the designated Prescription Drug User Fee Act (PDUFA) action date. Five main Phase 3 and one Phase 4 double-blind, placebo-controlled clinical trials informed the NDA submission.
- 09 May 2017 Results assessing the minimum clinically important difference and an optimum PAC-SYM cut-off score for defining responders using week 4 data (n=2884) from six phase 3 and 4 trials of prucalopride in chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT00488137), presented at the Digestive Disease Week 2017.
- 01 Dec 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.