NCT05923086 Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.
| NCT ID | NCT05923086 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Orexa BV |
| Condition | Ileus Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2024-01-11 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 126 participants in total. It began in 2024-01-11 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05923086 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Ileus Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05923086 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05923086 currently recruiting?
Yes, NCT05923086 is actively recruiting participants. Contact the research team at ardpeeters@orexa.nl for enrollment information.
Where is the NCT05923086 trial being conducted?
This trial is being conducted at Bonn, Germany, Düsseldorf, Germany, Wolfsburg, Germany.
Who is sponsoring the NCT05923086 clinical trial?
NCT05923086 is sponsored by Orexa BV. The trial plans to enroll 126 participants.