Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.
ConditionIleus Postoperative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorOrexa BV
About this trial
This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.
Eligibility criteria
Qualifiers
Patient must be able to understand the requirements of the study and give written informed consent prior to study start.
Female patients aged between 18 and 75 years (both inclusive).
Gynecologic surgery performed completely by longitudinal laparotomy.
Patient with ECOG Performance status up to 1.
Disqualifiers
Patient has a history of gastrectomy, total colectomy, stoma creation, short bowel syndrome.
Patient has pre-operative ileus.
Patient is taking opioid analgesics longer than two post-operative days, exceeding a dosing of 35 mg morphine equivalent per day.
Chemotherapy treatment within 10 days after longitudinal surgery.
Trial design
Treatments tested in this trial
- ORE001
- Placebo
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Orexa BV
Lead sponsor
QPS Holdings LLC
Collaborator
Source ClinicalTrials.gov