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Study on the Effects of Oral Lidocaine (ORE-001) on Food Intake in Underweight Elderly Patients

InvestigationalNo 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 studying the effects of a medication called ORE-001, which is an oral form of lidocaine, on elderly individuals who are underweight. The purpose of the study is to see if ORE-001 can help increase food intake and improve overall health and wellbeing in these individuals. Lidocaine is commonly known as a local anesthetic and is also used to treat irregular heartbeats, but in this study, it is being tested for its potential benefits in increasing appetite.

Participants in the study will be randomly assigned to receive either the ORE-001 medication or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will last for a period of 42 days, during which the participants' food intake will be monitored on specific days, such as day 1 and day 42, to assess any changes. The study aims to determine if there is an increase in the amount of food consumed during a standardized lunch provided to the participants.

Throughout the study, various aspects of the participants' health will be observed, including changes in body weight and appetite sensations. The study will also monitor any side effects that may occur during the trial period. By the end of the study, researchers hope to gather valuable information on whether ORE-001 can effectively help underweight elderly individuals improve their nutritional intake and overall health.

The research process

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

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, body mass index (BMI), and understanding of the study requirements.
Participants must provide written informed consent before proceeding.
Step 2
Baseline measurements
Baseline measurements are taken, including the weight of food intake during a standardized lunch and body weight.
Visual Analogue Scale (VAS) scores for appetite sensations and gastrointestinal (GI) symptoms are recorded.
Step 3
Medication administration
Participants receive either the study medication, ORE-001 (oral lidocaine), or a placebo. The tablets are film-coated and taken orally.
The dosage and frequency are determined by the study protocol, with adjustments made as necessary during the dose titration phase.
Step 4
Treatment days 1 to 42
On treatment days 1, 7, 14, and 42, the weight of food intake during a standardized lunch is measured again.
VAS scores for appetite sensations and GI symptoms are recorded on these days.
Body weight is monitored on treatment days 1, 7, 14, and 42.
Step 5
Final assessment
On treatment day 42, a final assessment is conducted, including the SF-6D score, PGI-S score, and PGI-I score.
Any treatment-emergent adverse events (AEs) or serious adverse events (SAEs) are documented up to the end of the study.

Who can join the trial?

5 criteria

The participant must be able to understand what the study involves and agree to it by signing a written consent form before the study begins.
Both females and males who are between the ages of 65 and 85 years can participate.
The participant's BMI (Body Mass Index) must be 20 or less at the start of the study. BMI is a measure that uses height and weight to estimate body fat.
Male participants must take steps to prevent pregnancy in their female partners who can have children during the study. This includes using medically approved birth control methods like hormonal contraception (such as pills or injections), female sterilization (like tubal ligation), or male sterilization (vasectomy). They must also agree not to donate sperm while in the study. These precautions are not needed if the female partner is postmenopausal, meaning she has stopped having menstrual periods.
If a male participant's female partner becomes pregnant during the study, he must ask her permission to inform the study investigator. If she agrees, the pregnancy will be monitored, and important health information may be collected to ensure proper follow-up. No information will be collected without her consent.

Who cannot join the trial?

1 criterion

Individuals who are underweight cannot participate. Being underweight means having a body weight that is lower than what is considered healthy for your height and age.

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Investigated drugs

ORE-001 (oral lidocaine) is being studied to see if it can help increase the amount of food intake in underweight elderly participants. This medication is taken by mouth and is being tested to determine its safety and effectiveness in improving appetite and food consumption over a period of time.

Lidocaine Hydrochloride Monohydrate

What is already known about the treatment

ORE-001 – This medication is administered orally and is currently being studied in clinical trials for its potential to help underweight elderly individuals increase their food intake. It is in the phase 2 stage of clinical trials, where its safety and effectiveness are being evaluated. The main therapeutic indication for ORE-001 is to address underweight conditions by potentially enhancing appetite or food consumption. The mechanism of action involves the use of lidocaine, which may influence sensory pathways related to appetite regulation. ORE-001 is classified pharmacologically as a local anesthetic, though its application in this trial is focused on its effects when taken orally.

Investigated diseases

Underweight – Underweight is a condition where an individual has a body weight that is considered too low to be healthy. It is often determined by a Body Mass Index (BMI) that is below the normal range. People who are underweight may experience a lack of energy, weakened immune function, and potential nutrient deficiencies. The condition can result from various factors, including inadequate food intake, high physical activity, or underlying health issues. Over time, being underweight can affect growth and development, particularly in children and adolescents. It is important to address the underlying causes to improve overall health and well-being.