Authorised Therapeutic exploratory (Phase II) Inflammatory Bowel disease

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

EU CTIS ID: 2023-508224-35-01

What this study is testing

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.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.