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

NCT05724069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-08-03

Study results available
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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

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.

Sponsors & Collaborators

  • Alfasigma S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2023-04-12
Completion
2023-04-12

Countries

  • Belgium
  • Italy
  • Spain

Study Locations

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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 NCT05724069 on ClinicalTrials.gov