Preventing gastrointestinal issues after abdominal surgery

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

This study is testing a new drug to see if it can help prevent stomach problems after abdominal surgery in women.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Orexa BV (Industry-sponsored)
• Drugs / interventions: Chemotherapy
• Locations: 3 sites (Bonn and 2 other locations)
• Trial ID: NCT05923086 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, double-blind, placebo-controlled phase 2 pilot study aims to evaluate the efficacy of ORE-001 in preventing postoperative ileus in female patients undergoing longitudinal laparotomy. Up to 126 participants will be randomized to receive either the study drug or a placebo before their main meal on the first postoperative day. Efficacy will be assessed using the I-FEED score and Visual Analogue Scale for abdominal pain, along with quality of life measurements using the SF-36 questionnaire. Safety assessments will include monitoring adverse events, vital signs, and laboratory tests throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 75 who are scheduled for gynecologic surgery via longitudinal laparotomy.

Not a fit: Patients with a history of gastrointestinal surgeries, pre-operative ileus, or those on high doses of opioid analgesics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce gastrointestinal disturbances and improve recovery outcomes for patients after abdominal surgery.

How similar studies have performed: Previous studies have shown promise in using local anesthetics for postoperative pain management, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Patient must be able to understand the requirements of the study and give written informed consent prior to study start.
2. Female patients aged between 18 and 75 years (both inclusive).
3. Gynecologic surgery performed completely by longitudinal laparotomy.
4. Patient with ECOG Performance status up to 1.
5. Patient is highly likely to comply with the protocol and complete the study.
6. Patient agrees to be scheduled for peridural catheter (PDC).

Exclusion Criteria:

1. Patient has a history of gastrectomy, total colectomy, stoma creation, short bowel syndrome.
2. Patient has pre-operative ileus.
3. Patient is taking opioid analgesics longer than two post-operative days, exceeding a dosing of 35 mg morphine equivalent per day.
4. Chemotherapy treatment within 10 days after longitudinal surgery.
5. Smoking during the hospital stay.
6. Any contraindication as per summary of product characteristic for the usage of local anesthetics for PDC.
7. History of uncontrolled (at the discretion of the Investigator) cardiovascular, renal and/or hepatic failure.
8. History of severe allergic or anaphylactic reactions, especially to local anesthetics.
9. Clinically significant (at the discretion of the Investigator) deviation from the normal laboratory values.
10. Clinically significant (at the discretion of the Investigator) abnormal ECG.
11. 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).
12. 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.
13. Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
14. Pregnancy or planning to become pregnant during the study.
15. Any other condition, which in the opinion of the Investigator precludes the patient's participation in the study.
16. Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the Sponsor.

Where this trial is running

Bonn and 2 other locations

• Universitätsklinikum Bonn (UKB). — Bonn, Germany (Recruiting)
• Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus — Düsseldorf, Germany (Recruiting)
• Klinikum Wolfsburg — Wolfsburg, Germany (Recruiting)

Study contacts

• Study coordinator: Ard Peeters, Prof.

Conditions Ileus Postoperative; local anesthetic