drugset / Trial / NCT04887818

Diltiazem Ointment With Lidocaine vs. Nifedipine Ointment With Lidocaine Ointment for Treatment of Chronic Anal Fissure

NCT04887818

Phase 2/3 Unknown 430 enrolled University of Calgary
RandomizedParallel-groupTriple-blindTreatment

Summary

Anal fissure is a common anorectal diseases characterized by tear of the anoderm from the dentate line to the anal verge leading to pain and bleeding during and post defecation. It may be a benign disease, but patients suffering from disease report significantly impacted quality of life especially when it becomes chronic. Several treatment modalities have been studied for chronic anal fissure, and topical calcium channel blockers (CCB) showed promising benefit and side effect profile in treatment of chronic anal fissure. Topical Diltiazem and Nifedipine are currently widely used CCBs for chronic anal fissure after multiple studies showing their benefits compared to different agents or modalities. To the investigators' knowledge, there is no study comparing the efficacy of topical Diltiazem and Nifedipine directly. The investigators aim to design a pragmatic randomized clinical trial to compare the efficacy, and side effect profile of topical Nifedipine and Diltiazem in treatment of chronic anal fissure.

Timeline

Start
2021-06
Primary completion
2021-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Diltiazem Small molecule 2 % Topical
Comparator Nifedipine Other / unclassified 0.3 % Topical
Background Lidocaine Other / unclassified 1.5 % Topical