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Study on Oral Lidocaine for Reducing Gastrointestinal Issues in Patients After Abdominal Surgery

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have undergone a type of abdominal surgery called a longitudinal laparotomy. The study is investigating the effectiveness of a medication called oral lidocaine, also known by its code name ORE-001, in preventing gastrointestinal issues that can occur after this surgery. These issues can include discomfort or intolerance in the digestive system, as well as a condition known as postoperative ileus, where the intestines do not function properly after surgery.

The purpose of the study is to see if oral lidocaine can help reduce these gastrointestinal problems compared to a placebo, which is a tablet that looks like the medication but does not contain any active ingredients. Participants in the study will be randomly assigned to receive either the oral lidocaine or the placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored for changes in their gastrointestinal symptoms, using a scoring system called the I-FEED score, which helps measure the severity of these symptoms. The study will track these scores at various points after surgery to determine the effectiveness of the treatment. The study will also monitor for any side effects or adverse events that may occur during the treatment period. The goal is to gather information that could lead to better management of gastrointestinal issues following abdominal surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written informed consent, confirming understanding of the study requirements.

    Eligibility includes being a female aged 18 to 75 years, having undergone gynecologic surgery via longitudinal laparotomy, and having an ECOG Performance status of up to 1.

  2. Step 2

    Medication administration

    The patient will receive either oral lidocaine (ORE-001) or a placebo. The medication is administered in the form of film-coated tablets.

    The purpose of the medication is to prevent gastrointestinal disturbance and intolerance following surgery.

  3. Step 3

    Monitoring and assessment

    The primary goal is to evaluate the I-FEED score on the third day after surgery (POD3). The I-FEED score measures gastrointestinal function.

    Secondary assessments include I-FEED scores on days 1, 2, and from day 4 up to day 8, with possible extension to day 12.

  4. Step 4

    Safety and side effects

    Monitoring for any adverse events that may arise during the study, including serious adverse events, is continuous until the end of the study.

    Changes in vital signs, ECG, laboratory tests, and physical examinations are tracked from the start to the end of the study.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by May 31, 2024.

    The patient's participation involves regular assessments and adherence to the study protocol until the end of the study.

Who can join the trial?

6 criteria

  • The patient must be able to understand what the study involves and agree to participate by signing a written consent form.
  • The patient must be a female aged between 18 and 75 years old, including both ages.
  • The patient must have had gynecologic surgery done entirely through a **longitudinal laparotomy**, which is a type of surgical cut made along the length of the abdomen.
  • The patient must have an **ECOG Performance status** of up to 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must be very likely to follow the study rules and finish the study.
  • The patient must agree to have a **peridural catheter (PDC)**, which is a small tube placed near the spine to help manage pain.

Who cannot join the trial?

4 criteria

  • Patients who have had a **longitudinal laparotomy**. This is a type of surgery where a long cut is made along the abdomen.
  • Only **female** patients are eligible, so male patients cannot participate.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, are not included.
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Investigated drugs

ORE-001 is an oral medication being studied for its potential to prevent gastrointestinal disturbances and intolerance in patients who have undergone a longitudinal laparotomy. The trial aims to see if this medication can reduce the occurrence of postoperative ileus, a condition where the intestines do not function properly after surgery. The effectiveness of ORE-001 is being compared to a placebo by evaluating patients' postoperative I-FEED scores on the third day after surgery.

What is already known about the treatment

Lidocaine (ORE-001) – This medication is administered orally and is currently being studied in clinical trials to assess its effectiveness in preventing gastrointestinal disturbances in patients after abdominal surgery. It is in the phase 2 stage of clinical trials, which means it is being tested for efficacy and safety. The main therapeutic indication for this medication is to reduce gastrointestinal intolerance and postoperative ileus following surgery. Lidocaine works by blocking sodium channels at the molecular level, which helps to reduce nerve signal transmission and can alleviate pain and discomfort. It is classified pharmacologically as a local anesthetic.

Investigated diseases

Postoperative Ileus – This condition occurs when the intestines temporarily stop moving after surgery, leading to a delay in the normal movement of food and waste through the digestive tract. It is commonly seen after abdominal surgeries, such as a longitudinal laparotomy. Symptoms may include bloating, abdominal pain, nausea, and a lack of bowel movements or gas. The condition typically resolves on its own as the intestines gradually regain their normal function. Monitoring and supportive care are often necessary to manage symptoms and ensure recovery.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-503113-31-01Protocol codeORE001PhIIPOIEstimated enrolment126 patientsSponsorOrexa B.V.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).