Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.

NCT ID: NCT05923086

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2025-12-31

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.

Detailed Description

After assessing eligibility during a screening period (up to 4 weeks before planned surgery), up to 126 female patients are planned to be randomized to one of the two treatment groups.

After the surgery, at POD1 (Post Operative Day 1), all patients will receive the oral study drug (ORE-001 4x 100 mg or 4x placebo) 15-30 minutes before intake of the semi-solid main meal (lunch).

Clinical assessments of efficacy will be conducted based on I-FEED score and VAS (Visual Analogue Scale) abdominal pain score at POD1 to POD8 (or up to POD12 if extended), and the impact of the treatment on the Quality of Life (QoL) of the patients at POD8 (or at POD9 up to POD12 if extended) and at Follow up (FU) in comparison to Baseline values. The impact of the treatment on the QoL will be done by using the specific 36-Item Short Form Survey Instrument (SF-36) QoL questionnaire.

Adverse events (AEs) will be recorded from POD1 to EOS continuously, concomitant medication, and other assessments including vital signs and body weight will be recorded throughout the study (Screening to EOS (End Of Study)).

Urine pregnancy tests (only for females of childbearing potential) will be performed at Screening and Baseline. 12-lead ECG will be performed at Screening, Baseline, POD1 and at Day after last study drug administration.

Safety laboratory assessments on blood (hematology and biochemistry) and urine (routine dip stick test) will be conducted at Screening, Baseline, POD1 and from POD4 every second day until one day after last IMP administration to assess for any changes in the safety endpoints.

Blood albumin will be analyzed on Screening, Baseline, and every POD until one day after last IMP administration to assess for any changes in the safety endpoints.

Interleukin 6 will be analyzed at POD1 and POD6. Patients prematurely terminating the study after administration of at least one dose of the study drug should be subjected to a final examination including safety laboratory assessment.

Conditions

Ileus Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo treatment (4 tablets)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administration before major meal

ORE001

ORE001 treatment (4 tablets)

Group Type: EXPERIMENTAL

ORE001

Intervention Type: DRUG

Administration before major meal

Interventions

ORE001

Administration before major meal

Intervention Type: DRUG

Placebo

Administration before major meal

Intervention Type: DRUG

Other Intervention Names

Lidocaine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

QPS Holdings LLC

INDUSTRY

Sponsor Role: collaborator

Orexa BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Bonn (UKB).

Bonn, , Germany

Site Status: RECRUITING

Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus

Düsseldorf, , Germany

Site Status: RECRUITING

Klinikum Wolfsburg

Wolfsburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ard Peeters, Prof.

Role: CONTACT

ardpeeters@orexa.nl

0652383983

Facility Contacts

A Mustea, Prof

Role: primary

Other Identifiers

CT-2022-503113-31

Identifier Type: -

Identifier Source: org_study_id