Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.
NCT05923086 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126
Last updated 2024-10-03
Summary
This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.
Conditions
- Ileus Postoperative
Interventions
- DRUG
-
ORE001
Administration before major meal
- DRUG
-
Administration before major meal
Sponsors & Collaborators
-
QPS Holdings LLC
collaborator INDUSTRY -
Orexa BV
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-11
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Germany
Study Locations
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