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Anti-fungal

Itraconazole + Terbinafine for Crohn's Disease (CD-IT Trial)

Phase 2

Recruiting

Led By Edmond-Jean Bernard, MD

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with the capacity to provide informed consent

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 weeks

Awards & highlights

CD-IT Trial Summary

This trial will compare the effectiveness of itraconazole and terbinafine against placebo in treating mild to moderate Crohn's disease.

Who is the study for?

This trial is for adults with mild to moderate Crohn's Disease confirmed by endoscopy or radiology within the last 6 months. Women who can have children must test negative for pregnancy and use double contraception. Participants need a certain disease severity score, cannot be pregnant, breastfeeding, or planning pregnancy during the study, and should not have severe liver or kidney issues or be on conflicting medications.Check my eligibility

What is being tested?

The trial tests itraconazole (400 mg/day) and terbinafine (500 mg/day), both antifungal medications, against placebos to see if they help with Crohn's Disease symptoms. Patients will take these orally every day to compare their effectiveness in treating the condition.See study design

What are the potential side effects?

Itraconazole may cause heart problems like congestive heart failure and arrhythmias; it can also affect liver enzymes leading to potential liver damage. Terbinafine might lead to digestive issues, changes in taste sensation, headaches, dizziness or skin reactions.

CD-IT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand and can agree to the study's procedures and risks.

CD-IT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the response of itraconazole and terbinafine therapy compared to placebo in subjects with CD, assessed by the Modified Harvey Bradshaw Index (HBI).

Secondary outcome measures

To evaluate the effect of study treatment on the primary endpoint in the subgroup of patients with positive ASCA (as measured on frozen plasma samples at end of the study).

To evaluate the response of the itraconazole and terbinafine therapy compared to placebo in subjects with CD on clinical remission assessed by the HBI.

To evaluate the response of the itraconazole and terbinafine therapy compared to placebo in subjects with CD on endoscopic response assessed by the Simplified Endoscopic Score for Crohn's disease (SES-CD).

+1 more

Other outcome measures

Exploratory analyses using genetic data (pharmacogenomic and metagenomics) as well as microbiotic testing will be described at a later time point and in a separate document.

To evaluate steroid use between active and placebo groups at study completion.

CD-IT Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Itraconazole and TerbinafineActive Control1 Intervention

During the first 4 weeks itraconazole will be administered alone at 200 mg twice daily, followed by itraconazole 200 mg twice daily and terbinafine 250 mg twice daily for the remaining 16 weeks. Both drugs will be administered orally.

Group II: PlaceboPlacebo Group1 Intervention

During the first 4 weeks a placebo will be administered alone at 200 mg twice daily, followed by placebo 200 mg twice daily and another placebo 250 mg twice daily for the remaining 16 weeks. Both placebos will be administered orally.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor

120 Previous Clinical Trials

68,751 Total Patients Enrolled

Edmond-Jean Bernard, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

Jean-Claude Tardif, MDPrincipal InvestigatorMontreal Heart Institute (MHI)

15 Previous Clinical Trials

18,664 Total Patients Enrolled

Media Library

Itraconazole (Anti-fungal) Clinical Trial Eligibility Overview. Trial Name: NCT05049525 — Phase 2

Crohn's Disease Research Study Groups: Placebo, Itraconazole and Terbinafine

Crohn's Disease Clinical Trial 2023: Itraconazole Highlights & Side Effects. Trial Name: NCT05049525 — Phase 2

Itraconazole (Anti-fungal) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05049525 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enrolled in this clinical experiment?

"Affirmative. According to the clinicaltrials.gov portal, this research project is currently recruiting volunteers; it was first posted on February 22nd 2022 and last modified April 20th 2022. 68 participants from 3 different sites are necessary for completion of the trial."

Answered by AI

Is this research endeavor unprecedented in its approach?

"At present, 16 distinct clinical trials for Itraconazole and Terbinafine are in progress across 46 cities located within 14 different nations. This research initially commenced back in 2014 under the auspices of AstraZeneca with a sample size of 39 participants; since then, 234 more studies have been conducted."

Answered by AI

Is this research recruiting participants at present?

"As reported on clinicaltrials.gov, this survey is presently seeking volunteers. The study was first published on February 22nd 2022 and last edited on April 20th 2022."

Answered by AI

Who is eligible to enroll in this medical research program?

"Admission to this trial necessitates patients suffering from an inflammatory bowel illness, and they must also be within the age range of 18-65. In total, 68 participants may join the study."

Answered by AI

Does this research accept individuals over the age of forty?

"For eligibility in this medical trial, patients must be of legal age and under the age of retirement."

Answered by AI

To what ailments are Itraconazole and Terbinafine typically prescribed?

"Itraconazole and Terbinafine are generally prescribed to treat fungal infections, but can also prove beneficial for patients with tinea cruris, tinea corporis, or severe cases of the latter."

Answered by AI

Are Itraconazole and Terbinafine officially sanctioned by the Food & Drug Administration?

"Our team's assessment for the safety of Itraconazole and Terbinafine is a 2, as this clinical trial has not yet provided evidence affirming efficacy but there is data confirming its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease

2022. "Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05049525.

All > Inflammatory Bowel Disease > Crohns Disease