Efficacy and Safety of GTN vs. Nifedipine in Acute Anal Fissure: A Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2025-05-10

Brief Summary

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The goal of this clinical trial is to compare the therapeutic efficacy and safety profile of Glyceryl Trinitrate (GTN) and Nifedipine ointments in the treatment of acute anal fissures in adults. The main questions it aims to answer are:

Which ointment is more effective in promoting fissure healing and symptom relief? What are the adverse effects associated with each treatment? Researchers will compare GTN and Nifedipine ointments to determine which provides better symptom resolution with fewer side effects.

Participants will:

Apply GTN or Nifedipine ointment topically twice daily for four weeks Attend follow-up visits for symptom assessment and adverse effect monitoring

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Detailed Description

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Background and Rationale:

Anal fissures are painful linear tears in the anoderm, commonly caused by trauma from hard stool passage, leading to increased internal anal sphincter tone and ischemia. Acute fissures typically heal within six to eight weeks, while chronic fissures persist beyond this period. First-line treatment includes non-surgical options such as topical pharmacotherapy to reduce sphincter spasm and improve mucosal blood flow.

Glyceryl Trinitrate (GTN) and Nifedipine are widely used topical agents for anal fissure management. GTN acts as a nitric oxide donor, reducing sphincter tone via smooth muscle relaxation, though it is often associated with headaches. Nifedipine, a calcium channel blocker, lowers sphincter tone by inhibiting calcium influx into smooth muscle cells and has a more favorable side effect profile. Despite their widespread use, their comparative efficacy and safety remain a subject of debate.

This randomized controlled trial (RCT) aims to compare GTN and Nifedipine ointments in acute anal fissure treatment, evaluating symptom resolution, healing rates, and adverse effects to determine the optimal therapeutic choice.

Study Overview:

This double-blind, randomized, parallel-arm clinical trial will compare GTN and Nifedipine in patients with acute anal fissures. Participants will be allocated into:

GTN Group: Receiving either 0.2% or 0.4% GTN ointment, applied twice daily for four weeks.

Nifedipine Group: Receiving either 0.2% or 0.5% Nifedipine ointment, applied twice daily for four weeks.

The primary outcome is healing rate at four weeks, with secondary outcomes including pain reduction, side effects, patient satisfaction, and recurrence rates over six months.

Data Analysis:

Collected data will undergo statistical analysis using Chi-square tests, ANOVA, Kaplan-Meier survival analysis, and logistic regression modeling to identify treatment effectiveness and predictors of success.

Ethical Considerations:

The study is approved by the Federal Government Polyclinic Ethics Review Board, with written informed consent obtained from participants. All procedures comply with Good Clinical Practice (GCP) guidelines, and data confidentiality will be strictly maintained.

Expected Impact:

This study aims to refine treatment protocols for acute anal fissures, offering evidence-based guidance on the most effective and safest medical therapy, potentially reducing the need for surgical intervention.

Conditions

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Acute Anal Fissure Anal Pain Anorectal Disorders Sphincter Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, double-blind, parallel-arm clinical trial evaluating the efficacy and safety of GTN (0.2% and 0.4%) versus Nifedipine (0.2% and 0.5%) in the treatment of acute anal fissures.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Participants do not know which specific treatment they are receiving, and investigators assessing outcomes are also blinded. However, care providers and data analysts are aware of group assignments.

Study Groups

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Arm 1: GTN 0.2%

Participants in this arm will apply 0.2% Glyceryl Trinitrate (GTN) ointment twice daily for four weeks. The primary goal is to assess its efficacy in healing acute anal fissures and symptom relief while monitoring for side effects such as headaches and dizziness.

Group Type ACTIVE_COMPARATOR

Glyceryl Trinitrate (GTN) 0.2% Ointment

Intervention Type DRUG

Participants will apply 0.2% Glyceryl Trinitrate (GTN) ointment to the anal region twice daily for four weeks. GTN functions as a nitric oxide donor, reducing internal anal sphincter tone to improve blood flow and promote fissure healing. The study aims to assess its effectiveness in symptom relief, fissure healing, and associated side effects such as headaches and dizziness.

Arm 2: GTN 0.4%

Participants in this arm will apply 0.4% Glyceryl Trinitrate (GTN) ointment twice daily for four weeks. This higher concentration aims to determine the dose-dependent efficacy and side effect profile compared to 0.2% GTN

Group Type ACTIVE_COMPARATOR

Glyceryl Trinitrate (GTN) 0.4% Ointment

Intervention Type DRUG

Participants will apply 0.4% Glyceryl Trinitrate (GTN) ointment twice daily for four weeks. This increased concentration aims to determine dose-dependent efficacy and adverse effects in treating acute anal fissures. GTN acts by relaxing smooth muscle, decreasing sphincter tone, and enhancing mucosal blood flow to promote healing.

Arm 3: Nifedipine 0.2%

Participants in this arm will apply 0.2% Nifedipine ointment twice daily for four weeks. The study will evaluate its effectiveness in fissure healing, pain relief, and incidence of adverse effects such as local irritation or hypotension.

Group Type ACTIVE_COMPARATOR

Nifedipine 0.2% Ointment

Intervention Type DRUG

Participants will apply 0.2% Nifedipine ointment twice daily for four weeks. Nifedipine, a calcium channel blocker, reduces sphincter tone by inhibiting calcium influx into smooth muscle cells, leading to improved fissure healing. This arm will assess its effectiveness in symptom relief and healing rates, with a focus on side effects such as local irritation or hypotension.

Arm 4: Nifedipine 0.5%

Participants in this arm will apply 0.5% Nifedipine ointment twice daily for four weeks. This higher concentration will assess whether increased potency provides superior symptom resolution and healing rates while monitoring potential side effects.

Group Type ACTIVE_COMPARATOR

Nifedipine 0.5% Ointment

Intervention Type DRUG

Participants will apply 0.5% Nifedipine ointment twice daily for four weeks. This higher concentration is used to evaluate whether increased potency provides superior symptom resolution and healing rates compared to 0.2% Nifedipine. The study will also assess any potential adverse effects, including local irritation, dizziness, and hypotension.

Interventions

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Glyceryl Trinitrate (GTN) 0.2% Ointment

Participants will apply 0.2% Glyceryl Trinitrate (GTN) ointment to the anal region twice daily for four weeks. GTN functions as a nitric oxide donor, reducing internal anal sphincter tone to improve blood flow and promote fissure healing. The study aims to assess its effectiveness in symptom relief, fissure healing, and associated side effects such as headaches and dizziness.

Intervention Type DRUG

Glyceryl Trinitrate (GTN) 0.4% Ointment

Participants will apply 0.4% Glyceryl Trinitrate (GTN) ointment twice daily for four weeks. This increased concentration aims to determine dose-dependent efficacy and adverse effects in treating acute anal fissures. GTN acts by relaxing smooth muscle, decreasing sphincter tone, and enhancing mucosal blood flow to promote healing.

Intervention Type DRUG

Nifedipine 0.2% Ointment

Participants will apply 0.2% Nifedipine ointment twice daily for four weeks. Nifedipine, a calcium channel blocker, reduces sphincter tone by inhibiting calcium influx into smooth muscle cells, leading to improved fissure healing. This arm will assess its effectiveness in symptom relief and healing rates, with a focus on side effects such as local irritation or hypotension.

Intervention Type DRUG

Nifedipine 0.5% Ointment

Participants will apply 0.5% Nifedipine ointment twice daily for four weeks. This higher concentration is used to evaluate whether increased potency provides superior symptom resolution and healing rates compared to 0.2% Nifedipine. The study will also assess any potential adverse effects, including local irritation, dizziness, and hypotension.

Intervention Type DRUG

Other Intervention Names

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GTN 0.2% Nitroglycerin 0.2% Ointment GTN 0.4% Nitroglycerin 0.4% Ointment Nifedipine Gel 0.2% Nifedipine 0.2% Nifedipine Gel 0.5% Nifedipine 0.5%

Eligibility Criteria

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Inclusion Criteria

* Participants must meet all of the following criteria to be eligible for the study:
* Age 18 to 65 years (to exclude elderly patients with different treatment responses).
* Diagnosis of acute anal fissure based on clinical examination (symptom duration ≤6 weeks).
* Willingness to participate in the study and provide written informed consent.
* Availability for follow-up visits during the study period.
* No prior use of GTN or Nifedipine for anal fissure within the past one month.
* Presence of at least one of following symptoms: Anal pain, Bleeding during or after defecation and Difficulty in defecation

Exclusion Criteria

* Participants will be excluded if they meet any of the following criteria:
* History of chronic anal fissure (\>6 weeks duration) or prior anal fissure treatment within the past month.
* Pregnant or breastfeeding women.
* Known allergy or hypersensitivity to Glyceryl Trinitrate (GTN) or Nifedipine ointments.
* History of cardiovascular diseases or contraindications to GTN or Nifedipine (e.g., hypotension, severe heart disease).
* Presence of severe systemic diseases (e.g., uncontrolled diabetes, renal failure, autoimmune disorders) or conditions that may affect wound healing or medication tolerance.
* Use of other topical treatments for anal fissure within the past month.
* Secondary anal fissures associated with conditions e.g crohn's disease, tuberculosis, syphilis, HIV and other systemic diseases
* Previous anal surgery (including lateral internal sphincterotomy).
* History of recurrent anal fissures (\>2 previous episodes in the past year).
* Inability to comply with study requirements or follow-up visits.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No