NCT05724069

Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).

Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). A Multicenter, Double-blind, Placebo-controlled, Cross-over, Multiple (n=1) Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Alfasigma S.p.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of velusetrag once a day, compared to placebo, in subjects with CIPO.

Conditions

• Chronic Intestinal Pseudo-obstruction

Interventions

Type	Name	Description
DRUG	Velusetrag 15 mg once daily for 4 weeks.	Subjects will be randomly allocated in a blinded fashion to 1 out of the 4 treatment sequences (each sequence include 4 periods, 2 periods with velusetrag and 2 periods with placebo). There will be a wash-out period between each treatment period.
DRUG	Placebo once daily for 4 weeks.	Subjects will be randomly allocated in a blinded fashion to 1 out of the 4 treatment sequences (each sequence include 4 periods, 2 periods with velusetrag and 2 periods with placebo). There will be a wash-out period between each treatment period.

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2023-02-13
• Last updated: 2025-08-03
• Results posted: 2025-08-03

Locations

4 sites across 3 countries: Belgium, Italy, Spain