Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study to investigate the efficacy of oral lidocaine (ORE-001) in preventing gastrointestinal disturbance/intolerance in patients after longitudinal laparotomy

This research is looking into a new tablet called ORE-001, which contains a medicine called lidocaine, to see if it can reduce stomach upset and discomfort after a type of surgery called a longitudinal laparotomy. This is a significant abdominal operation, and sometimes patients experience digestive issues afterwards. The study is a 'Phase 2' trial, meaning it's an early step to check if the medicine is effective and safe in a small group of people. We want to see if patients taking ORE-001 have fewer or less severe stomach problems compared to those who receive a dummy pill (placebo). This will involve regularly checking how well patients are eating and feeling after their operation.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Orexa B.V.

Enrolment target

126

Start

12 Sep 2023

longitudinal laparotomy

What is this study about?

Imagine you're having an important operation on your tummy, perhaps a big cut down the middle. After such a surgery, it's quite common for people to have some digestive problems – maybe feeling sick, having trouble eating, or just generally feeling uncomfortable in their stomach. This can make recovery harder and longer.

This study is trying to find a way to make that recovery smoother. Researchers are testing a new medicine in tablet form, called ORE-001, which contains a substance called lidocaine. You might have heard of lidocaine as a numbing medicine; here, it's being explored to see if it can help the gut recover more quickly and reduce those uncomfortable stomach feelings after surgery.

The study is designed to be very careful. Some patients will receive the new medicine, while others will get a 'dummy' pill (called a placebo) that looks exactly the same but contains no active medicine. This way, the doctors can fairly compare how both groups recover and see if the new medicine really makes a difference. The main thing they'll be looking at is how well patients are eating and digesting a few days after their operation.

Key takeaways

This study is for women needing a specific major tummy operation.
It tests a new medicine (ORE-001) to help with stomach problems after surgery.
Participants will receive either the new medicine or a dummy pill.
The study measures how well patients eat and digest after their operation.
Close monitoring for safety and progress will occur for up to about 12 days.

Who may be eligible?

This study is specifically for women who are having a major tummy operation, what doctors call a 'longitudinal laparotomy'. To join, you need to be at least 18 years old – there's no upper age limit, as long as you're otherwise considered suitable by the study doctors.

Because this is a specific type of surgery and medicine, it means that men or people having different kinds of operations would not be able to take part. There will be other health requirements too, which the study team will explain in detail to make sure the study is right and safe for you.

The research needs participants who are having this particular surgery because it's precisely those people who might benefit from this medicine if it works. The study team will check your full medical history to ensure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I female?
Am I aged 18 or over?
Am I scheduled for a longitudinal laparotomy (a major tummy operation with a vertical cut)?
Am I able to consistently take tablets by mouth?
Am I willing to have regular health checks and blood tests?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several things. After your longitudinal laparotomy, you would be given either the new study medicine (ORE-001) or a dummy pill (placebo) to take regularly, as instructed by the study team. You wouldn't know which one you're taking, nor would your doctors, which helps make the results fair.

The research team will regularly check in with you, especially in the first few days after your operation. They will ask questions about how you're feeling, particularly about your stomach and how well you're eating and digesting food. This will be done using a special scoring system (called the I-FEED score).

You'll have regular checks of your vital signs (like blood pressure and heart rate), blood tests, and possibly ECGs (heart tracings) to monitor your health and ensure the medicine is safe. These checks will happen at set times throughout the study period, which could last up to about 12 days after your operation, or until you stop taking the study drug. All these assessments help the researchers understand the effects of the medicine.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be that the new medicine helps you recover more comfortably from your surgery by reducing stomach upset. However, it's also possible the medicine won't work for you, or you might receive the dummy pill. As with any new medicine, there's always a chance of side effects, which the study team will monitor very closely. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is a 'longitudinal laparotomy'?

It's a major operation on your tummy where the surgeon makes a cut, usually from top to bottom, to get to your organs.

Will I know if I'm getting the new medicine or the dummy pill?

No, neither you nor your doctors will know. This is called 'double-blind' and helps make the study results fair.

What does 'I-FEED score' mean?

It's a way for doctors to measure how well you're eating and digesting food after your surgery. A low score usually means you're doing well.

How long will I be in the study?

You'll be monitored closely for about 8 to 12 days after your surgery, or until you stop taking the study drug, for various checks.

What if I experience side effects?

The study team will carefully monitor you for any side effects and provide appropriate care. You should always tell them how you're feeling.