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

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

Inclusion Criteria6

  • 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.
  • Patient is highly likely to comply with the protocol and complete the study.
  • Patient agrees to be scheduled for peridural catheter (PDC).

Exclusion Criteria16

  • 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.
  • Smoking during the hospital stay.
  • Any contraindication as per summary of product characteristic for the usage of local anesthetics for PDC.
  • History of uncontrolled (at the discretion of the Investigator) cardiovascular, renal and/or hepatic failure.
  • History of severe allergic or anaphylactic reactions, especially to local anesthetics.
  • Clinically significant (at the discretion of the Investigator) deviation from the normal laboratory values.
  • Clinically significant (at the discretion of the Investigator) abnormal ECG.
  • Intake of any class 1B antiarrhythmic drugs if used for antiarrhythmic purpose (e.g., Lidocaine, Mexiletine, Phenytoin) and of any class 3 antiarrhythmic drugs - Kalium channel blockers (e.g., Amiodarone, Dronedarone, Sotalol, Ibutilide, Dofetilide, Bretylium).
  • Significant (at the discretion of the Investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection (especially with need of antibiotic treatment) within the past 2 weeks prior to study medication administration.
  • Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
  • Pregnancy or planning to become pregnant during the study.
  • Any other condition, which in the opinion of the Investigator precludes the patient's participation in the study.
  • Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the Sponsor.

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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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NCT05923086


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