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

Primary Purpose

Fissure in Ano, Rectal Diseases, Rectal Bleed

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
2% Diltiazem ointment with 1.5% lidocaine
0.3% Nifedipine ointment with 1.5% lidocaine
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fissure in Ano

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Topical diltiazem + lidocaine

Topical nifedipine + lidocaine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 7, 2021
Last Updated
May 12, 2021
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04887818
Brief Title
Diltiazem Ointment With Lidocaine vs. Nifedipine Ointment With Lidocaine Ointment for Treatment of Chronic Anal Fissure
Official Title
Assessment of Efficacy and Side Effects of Dlitiazem Ointment With Lidocaine vs. Diltiazem Ointment With Lidocaine for Treatment of Chronic Anal Fissure: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
Detailed Description
Anal fissure is a common anorectal diseases characterized by tear of the anoderm from the dentate line to the anal verge. It is a benign disease, but symptoms including stabbing pain during and post defecation, bleeding, and irritation lead to decreased quality of life. Acute anal fissure are superficial splits, and mostly heal spontaneously within 4 weeks with or without conservative management including high fibre diet and stool softeners. Chronic anal fissure is characterized by symptoms lasting longer than 2 months, and clinical findings of sentinel perianal skin tag, hypertrophied anal papilla, exposure of the underlying internal anal sphincter or anal cicatrization. The pathophysiology involves hypertonia of the internal anal sphincter leading to a reduction in mucosal blood flow, therefore poor healing tendency. Several treatment modalities have been studied for chronic anal fissure. Surgical therapy (ie. lateral internal sphincterotomy) has shown promising healing rate, but its role as first line treatment was limited by significant complications including permanent flatus or fecal incontinence. Chemical sphincterotomy was introduced as a promising first line treatment due to its safe side effect profile and comparable healing rate. Topical Nitro donor initially showed a reasonable healing rate, but it was associated with high rate of significant headache leading to early termination of the therapy. Calcium channel blockers (CCB) were then introduced to the market due to its known systemic vasodilator effect. Systemic administration of CCB is associated with various side effects including hypotension, positional hypotension, and flushing, but the topical agents were associated with minimal systemic side effects while demonstrating potent local vasodilator effect. Several randomized clinical trials have shown excellent healing rate, and safe side effect profile of both topical Diltiazem and Nifedipine. Currently, both agents are prescribed as the standard of care for first line treatment of symptomatic anal fissure. 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. This study will be a prospective, randomized, double-blinded study involving patients with chronic anal fissure undergoing 12-week treatment course of 2% Diltiazem ointment with 1.5% lidocaine vs. 0.3% Nifedipine ointment with 1.5% lidocaine. Patients with IBD, anorectal surgery, infection, radiation, instrumentation, obstetrical injuries, or patients who are currently pregnant will be excluded. Both the surgeons and the participants will be blinded from the agent being used. The participants will be followed up in the clinic at 3 months to evaluate patient reported outcome and physical exam findings of anal fissure. Primary outcome is the anal fissure related symptoms reported by the patients upon completion of the therapy. Physical exam findings will documented and to aid in assessment of the response to the therapy, but patient reported outcome will be the most important clinical information to assess efficacy of the therapy. Secondary outcome include rate of side effects, patient compliance rate, recurrence rate, and time from cure to recurrence. Recurrence is defined by return of symptoms related to anal fissure in patients who experienced resolution of symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fissure in Ano, Rectal Diseases, Rectal Bleed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial comparing efficacy and side effect profile of topical diltiazem + lidocaine vs. topical nifedipine + lidocaine
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical diltiazem + lidocaine
Arm Type
Experimental
Arm Title
Topical nifedipine + lidocaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
2% Diltiazem ointment with 1.5% lidocaine
Intervention Description
3 g of topical 2% diltiazem ointment with 1.5 % lidocaine applied in the perianal region circumferential q12h x 12 weeks
Intervention Type
Drug
Intervention Name(s)
0.3% Nifedipine ointment with 1.5% lidocaine
Intervention Description
3 g of topical 0.3% nifedipine ointment with 1.5 % lidocaine applied in the perianal region circumferential q12h x 12 weeks
Primary Outcome Measure Information:
Title
Perianal pain
Description
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.
Time Frame
12 weeks
Title
Anal bleeding
Description
Anal bleeding with defecation upon completion of 12-week therapy. Patient report of bleeding or no bleeding post defecation will be recorded.
Time Frame
12 weeks
Title
Perianal irritation
Description
Perianal irritation upon completion of 12-week therapy. Patient will report of presence of irritation or absence of irritation will be recorded.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Indraneel Datta, M.D., M.Sc.
Phone
(403) 264-6720
Email
Indraneel.datta@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Michael Kwan, M.D.
Phone
4036301248
Email
Michael.kwan@albertahealthservices.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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