RecruitingPhase 2NCT05923086

Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.

A Multi-center, Randomized, Double Blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy of ORE-001 in Preventing Gastrointestinal Disturbance/ Intolerance in Patients After Longitudinal Laparotomy

Sponsor

Orexa BV

Enrollment

126 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

Ileus Postoperative

Summary

This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ORE001 and a drug called Placebo for people with ileus postoperative. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGORE001

Administration before major meal

DRUGPlacebo

Administration before major meal

Locations(3)

Universitätsklinikum Bonn (UKB).

Bonn, Germany

Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus

Düsseldorf, Germany

Klinikum Wolfsburg

Wolfsburg, Germany

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