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

NCT04887818 | Unknown Phase 2 FDA Drug

• 1 other identifier: REB20-0239
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fissure in Ano; Rectal Diseases; Rectal Bleed

Outcome Measures

Primary Outcomes (3)

• Perianal pain

  Perianal pain with defecation upon completion of 12-week therapy. Visual analogue pain scale will be used with 0 being no pain, and 10 being the worst pain possible.

  12 weeks

• Anal bleeding

  Anal bleeding with defecation upon completion of 12-week therapy. Patient report of bleeding or no bleeding post defecation will be recorded.

  12 weeks

• Perianal irritation

  Perianal irritation upon completion of 12-week therapy. Patient will report of presence of irritation or absence of irritation will be recorded.

  12 weeks

Study Arms (2)

Topical diltiazem + lidocaine

EXPERIMENTAL

Drug: 2% Diltiazem ointment with 1.5% lidocaine

Topical nifedipine + lidocaine

ACTIVE COMPARATOR

Drug: 0.3% Nifedipine ointment with 1.5% lidocaine

Interventions

2% Diltiazem ointment with 1.5% lidocaine DRUG

3 g of topical 2% diltiazem ointment with 1.5 % lidocaine applied in the perianal region circumferential q12h x 12 weeks

Topical diltiazem + lidocaine

0.3% Nifedipine ointment with 1.5% lidocaine DRUG

3 g of topical 0.3% nifedipine ointment with 1.5 % lidocaine applied in the perianal region circumferential q12h x 12 weeks

Topical nifedipine + lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History or clinical findings consistent with chronic anal fissure including symptoms (sharp pain during and post defecation, bleeding, or perianal irritation) with duration over 2 months
• Physical exam findings of sentinel anal skin tag, hypertrophied anal papilla, exposure of the underlying internal anal sphincter or anal cicatrization.
• Patient with history of trial of other topical agents for chronic anal fissure may be included for participation, but will be stratified based on previous treatment as they may be less likely to respond to another topical agent.
• Patient with concomitant hemorrhoids will also be included.

You may not qualify if:

• Patients with history of inflammatory bowel disease, perianal abscess, perianal fistula, anal cancer, anorectal instrumentation, trauma, surgery, radiation, obstetrical injuries, or current pregnancy will be excluded.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Fissure in Ano; Rectal Diseases; Gastrointestinal Hemorrhage

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Anus Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial comparing efficacy and side effect profile of topical diltiazem + lidocaine vs. topical nifedipine + lidocaine

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: May 14, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)