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

NCT05049525 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-05-30

No results posted yet for this study

Summary

This study will evaluate the response of itraconazole and terbinafine therapy compared to placebo in patients with mild to moderate Crohn's disease (CD).

Conditions

Interventions

DRUG

Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.

Itraconazole capsules of 100 mg, antifungal agent. Terbinafine tablets 250 mg (as terbinafine hydrochloride), antifungal agent.

DRUG

Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally.

Matching placebo of itraconazole capsules of 100 mg, antifungal agent. Matching placebo of terbinafine tablets 250 mg, antifungal agent.

Sponsors & Collaborators

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Jean-Claude Tardif, MD · Montreal Heart Institute (MHI)

  • Edmond-Jean Bernard, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2024-02-28
Completion
2024-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05049525 on ClinicalTrials.gov