Analgesic effect of intravenous lidocaïne and its mechanisms in patients suffering from chronic inflammatory bowel disease (IBD) with abdominal pain.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHU De Liege

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

30 Sep 2024 → ongoing

Decision date (initial)

2024-07-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of the first phase of this project is to demonstrate a reduction in pain intensity of at least 50%, as assessed by a visual analog scale, after an intravenous lidocaine infusion in patients suffering from a chronic inflammatory bowel disease (IBD). The second phase aims at studying the changes in brain connectivity after an intravenous lidocaine infusion in a population of patients suffering from IBD with abdominal pain, and to compare these changes with those observed in a group of healthy volunteers.

Conditions and MedDRA coding

Inflammatory Bowel disease

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. The inclusion criteria for the WP1 are: patients suffering from abdominal pain (pain score >3 at least two days a week during the last month) in a context of IBD, both Crohn’s disease or UC, and recruited from the gastroenterology consultation of Prof. Edouard Louis, Prof. Catherine Reenaers and Dr Sophie Vieujean (CHU Liege), being 18 years old or more, women or men. The patient has to be under optimal treatment for the disease, which has to be controlled, with no IBD treatment modification in the past 3 months (left to the discretion of the gastroenterologist). All patients must be capable to speak, understand, read and write in French. For WP2, the inclusion criteria for the patients are the same as WP1. Recruited volunteers will not suffer from IBD nor chronic abdominal pain and will be matched to patients of the same WP according to the age, sex, weight, and height.

Exclusion criteria 1

1. The exclusion criteria for WP1 and WP2 will be the following: renal insufficiency (exclueded by a blood sample from maximum one year), hepatic insufficiency (exclueded by a blood sample from maximum one year), hypersensitivity to the active ingredient or to one of the excipients or to local anesthetics of the amide type, cardiac conduction disorders, cardiac insufficiency, ongoing anticoagulant therapy, history of convulsion, injection site infection, shock state, history of malignant hyperthermia, refusal of the patient, pregnancy, breast-feeding woman, ongoing treatment with analgesics specifically targeting neuropathic pain (pregabalin, gabapentin, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRI), serotonin and noradrenaline reuptake inhibitors (SNRI)), neurological or psychiatric disorders, seizures, history of alcohol or drug abuse. In addition, treatment of IBD cannot be modified during the trial. Patients are also excluded if they take medications that have interactions with lidocaine, including beta-blockers, digitalin derivatives, cimetidine, barbituric, rifampicin, isoprenaline, glucagon, phenytoin, tocainide, mexiletine, and amiodarone. An acute/sudden, severe, sharp and constant or worsening in intensity abdominal pain is also an exclusion criterion. For WP2, contraindications to MRI will be added as exclusion criteria, including metallic devices such as a pacemaker, vascular clips, some ocular implants, cochlear implants, stent for less than 6 months, …). A complete metal checklist will be verified with each participant before allowing them to enter the MRI suite.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. We hope to be able to reduce the background pain scores and decrease the frequency of hyperalgesia flare-ups, and thus reduce the psychosocial impacts associated in these patients.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHU De Liege

Sponsor organisation

CHU De Liege

Address

Avenue De L'hopital 1

City

Liege

Postcode

4000

Country

Belgium

Scientific contact point

Organisation

CHU De Liege

Contact name

Delphine Lejeune

Public contact point

Organisation

CHU De Liege

Contact name

Delphine Lejeune

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications