Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.

NCT05923086 | Recruiting Phase 2

• 1 other identifier: CT-2022-503113-31
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Ileus Postoperative

Keywords

local anesthetic

Outcome Measures

Primary Outcomes (1)

• I-FEED Post Operative Day 3

  To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD3. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

  Post Operative Day 3

Secondary Outcomes (12)

• I-FEED Post Operative Day 1

  Post Operative Day 1

• I-FEED Post Operative Day 2

  Post Operative Day 2

• I-FEED Post Operative Day 4

  Post Operative Day 4

• I-FEED Post Operative Day 5

  Post Operative Day 5

• I-FEED Post Operative Day 6

  Post Operative Day 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo treatment (4 tablets)

Drug: Placebo

ORE001

EXPERIMENTAL

ORE001 treatment (4 tablets)

Drug: ORE001

Interventions

ORE001 DRUG

Administration before major meal

Also known as: Lidocaine

ORE001

Placebo DRUG

Administration before major meal

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orexa BV: lead
• QPS Holdings LLC: collaborator

Study Sites (3)

Universitätsklinikum Bonn (UKB).

Bonn, Germany

RECRUITING

Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus

Düsseldorf, 40489, Germany

RECRUITING

Klinikum Wolfsburg

Wolfsburg, 38440, Germany

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ard Peeters, Prof.

CONTACT

0652383983; ardpeeters@orexa.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 28, 2023
• Study Start: January 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)