Trials Sponsors Conditions Drugs Pricing

Conditions

Anorexia nervosa

Outcome Measures

Primary Outcomes (1)

Difference between ORE-001 and placebo in change from baseline in VAS scores for satiety sensations on Day 28

Secondary Outcomes (8)

Difference between ORE-001 and placebo in change from baseline in late fullness (prior to lunch) in VAS scores for satiety sensations on Day 28
Difference between ORE-001 and placebo in change from baseline in VAS score for GI symptoms on Day 28
Difference between ORE-001 and placebo in change from baseline in body weight at Day 28.
Daily change from baseline in the weight of food and calorie intake per meal.
Difference between ORE-001 and placebo in change from baseline in total IEDOQL score on Day 28.
+3 more secondary outcomes

Interventions

Composition [mg/tablet]: Microcrystalline cellulose 243.9, Sodium bicarbonate 15.9, Hydroxypropyl methylcellulose 47.7, Sodium croscarmellose 4.5, Silicon dioxide 3.2, Magnesium stearate plant 3.2, Eudragit E PO Ready Mix 12.7Type not reported

ORE-001Type not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexfemale

Age GroupsAdult (18-64)

You may qualify if:

Patients must be able to understand the requirements of the study and give written informed consent prior to study start.
Female between 18 and 45 years of age (both inclusive).
Patients requiring hospitalization and under psychological treatment for anorexia nervosa for at least 3 months.

Sponsors & Collaborators

Orexa B.V.
Industrylead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (1)

Istituto Auxologico Italiano

Oggebbio, 28824, Italy

Leonardo Mendolicchio3290999692 l.mendolicchio@auxologico.it

Central Study Contacts

Bernardus Peeters

0031652383983 ardpeeters@orexa.nl

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

October 11, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-510499-30-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:34:30 UTC

Documents

D4_questionnaire_VAS

You may not qualify if:

Any contraindication as per summary of product characteristic for the usage of lidocaine.
Any other condition, including but not limited to epilepsy, myasthenia gravis, cardiac conduction disturbances, congestive heart failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with creatinine clearance (CrCl) less than 10 ml/min, which in the opinion of the investigator precludes the patient’s participation in the study.
Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the sponsor.
History of uncontrolled (at the discretion of the investigator) cardiovascular, renal, hepatic and/or liver failure.
History of severe allergic or anaphylactic reactions, especially to local anesthetics.
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 - potassium channel blockers (e.g., amiodarone, dronedarone, sotalol, ibutilide, dofetilide, bretylium).
Intake of concomitant medication that has an impact on stomach pH like proton pump inhibitors. These compounds may have an impact on the bioavailability of the ORE-001.
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, lactation, or planning to become pregnant during the study. Females of childbearing potential must have a negative pregnancy test prior to starting treatment and practice highly effective methods of birth control throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy). Highly effective contraceptives measures according to CTCG recommendation, version 1.2, 07 March 2024, are: a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral/intravaginal/transdermal or progestogen-only hormonal contraception associated with inhibition of ovulation: oral/ injectable/ implantable for at least 3 months prior to dosing and continuing through the study completion. b. Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) for at least 3 months prior to dosing and continuing through the study completion. c. Bilateral tubal occlusion. d. Vasectomized partner. e. Sexual abstinence. Note: Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate, history of vasomotor symptoms) or have FSH level of at least 40 U/ml at screening (to confirm menopause) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
Hypersensitivity to the IMP or to any excipients used in the formulation.

A Double-Blinded, Placebo-Controlled Exploratory Study to Investigate the Efficacy and Safety of Flexible dosing of Oral Lidocaine (ORE-001) to Reduce Abdominal Discomfort and Prevent Early Satiety in Anorexia Nervosa Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations