Acute Anal FissurePhase 4NCT06859554
Efficacy and Safety of GTN vs. Nifedipine in Acute Anal Fissure: A Clinical Trial
A Phase 4 study testing Glyceryl Trinitrate (GTN) 0.2% Ointment, Glyceryl Trinitrate (GTN) 0.4% Ointment and Nifedipine 0.2% Ointment in people with Acute Anal Fissure and Anal Pain, run by Hafiz Muhammad Hamza at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Anal Fissure, Anal Pain, Anorectal Disorders
- What is being tested?
- Glyceryl Trinitrate (GTN) 0.2% Ointment, Glyceryl Trinitrate (GTN) 0.4% Ointment and Nifedipine 0.2% Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 10 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Federal Government Polyclinic (Postgraduate Medical Institute)
Islamabad, Capital, 051
About this study
Official title: Assessing the Therapeutic Efficacy and Safety Profile of Glyceryl Trinitrate (GTN) and Nifedipine Ointments in Acute Anal Fissure Treatment: A Parallel-arm Clinical Trial
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
Read the detailed description
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
- Acute Anal Fissure, Anal Pain, Anorectal Disorders, Sphincter Spasm
- Being tested
- Glyceryl Trinitrate (GTN) 0.2% Ointment, Glyceryl Trinitrate (GTN) 0.4% Ointment, Nifedipine 0.2% Ointment, Nifedipine 0.5% Ointment
- Keywords
- Anal fissure treatment, Glyceryl Trinitrate (GTN), Nifedipine ointment, Randomized controlled trial (RCT), Pain relief in anal fissures
- Medical subject headings
- Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl Trinitrate (GTN) 0.2% OintmentDrug
Also called GTN 0.2%, Nitroglycerin 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.
Glyceryl Trinitrate (GTN) 0.4% OintmentDrug
Also called GTN 0.4%, Nitroglycerin 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.
Nifedipine 0.2% OintmentDrug
Also called Nifedipine Gel 0.2%, Nifedipine 0.2%
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.
Nifedipine 0.5% OintmentDrug
Also called Nifedipine Gel 0.5%, Nifedipine 0.5%
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: GTN 0.2% | Active comparator | 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. Receives: Drug: Glyceryl Trinitrate (GTN) 0.2% Ointment |
| Arm 2: GTN 0.4% | Active comparator | 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 Receives: Drug: Glyceryl Trinitrate (GTN) 0.4% Ointment |
| Arm 3: Nifedipine 0.2% | Active comparator | 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. Receives: Drug: Nifedipine 0.2% Ointment |
| Arm 4: Nifedipine 0.5% | Active comparator | 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. Receives: Drug: Nifedipine 0.5% Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate at 4 Weeks
The proportion of participants achieving complete epithelialization of the anal fissure on clinical examination at the end of four weeks.
Measured: 4 weeks
Secondary outcomes (4)
Change in Pain Scores (Visual Analog Scale [VAS])
Reduction in pain scores from baseline to post-treatment, measured using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain severity.
Measured: 4 weeks
Incidence and Severity of Adverse Effects
Assessment of drug-related side effects, including headache, dizziness, local irritation, and hypotension, recorded throughout the study duration.
Measured: 4 weeks
Patient Satisfaction with Treatment ( Self-validated Patient Satisfaction Score)
Evaluation of patient-reported satisfaction with treatment outcomes, assessed using a structured questionnaire.
Scoring System:
Patient satisfaction is assessed using the Self-validated Patient Satisfaction Score, with responses recorded on a 5-point Likert scale. The scoring system is as follows:
- Very satisfied = 5
- Somewhat satisfied = 4
- Neutral = 3
- Somewhat dissatisfied = 2
- Very dissatisfied = 1
- Higher scores indicate greater patient satisfaction with treatment outcomes.
Measured: 4 weeks
Time to Symptom Resolution
Duration until complete resolution of pain and cessation of rectal bleeding.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start17 Mar 2025
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hafiz Muhammad Hamza
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Government Polyclinic (Postgraduate Medical Institute)
- Responsible party
- Sponsor-investigator, Hafiz Muhammad Hamza, Federal Government Polyclinic (Postgraduate Medical Institute)
- Investigators
- Naveed Ullah Khan, Consultant surgery, HOD, Study chair, Federal Government Polyclinic (Postgraduate Medical Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859554
- Sponsor's protocol ID
- FGPC.1/12/2024
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, no final decision has been made regarding the sharing of individual participant data (IPD). Data sharing will be considered based on future research needs, ethical guidelines, and institutional policies. Any decision to share IPD will be made in compliance with data protection regulations and patient confidentiality standards.
Publications
Mustafa NA, Cengiz S, Turkyilmaz S, Yucel Y. Comparison of topical glyceryl trinitrate ointment and oral nifedipine in the treatment of chronic anal fissure. Acta Chir Belg. 2006 Jan-Feb;106(1):55-8. doi: 10.1080/00015458.2006.11679834.
PubMed 16612915Wang C, Ni J, Xiong Y, Chen J, Li B, Xu L. The efficacy of diltiazem, glyceryl trinitrate, nifedipine, minoxidil, and lidocaine for the medical management of anal fissure: a systematic review and network meta-analysis of randomized controlled trials. Int J Surg. 2025 Apr 1;111(4):3020-3029. doi: 10.1097/JS9.0000000000002263.
PubMed 39878173Momayez Sanat Z, Mohammadi Ganjaroudi N, Mansouri M. The Effect of Topical Nifedipine versus Diltiazem on the Acute Anal Fissure: A Randomized Clinical Trial. Middle East J Dig Dis. 2023 Apr;15(2):121-125. doi: 10.34172/mejdd.2023.330. Epub 2023 Apr 30.
PubMed 37546514Shrestha SK, Thapa PB, Maharjan DK, Tamang TY. Effectiveness of 0.2% Glyceryl Trinitrate and 0.5% Nifedipine in the Treatment of Chronic Anal Fissure. JNMA J Nepal Med Assoc. 2017 Jan-Mar;56(205):149-152.
PubMed 28598453
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Therapeutic Efficacy and Safety Profile of Glyceryl Trinitrate (GTN) and Nifedipine Ointments in Acute Anal Fissure Treatment: A Parallel-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06859554
- Acronym / sponsor ID
- FGPC.1/12/2024
- Conditions
- Acute Anal Fissure, Anal Pain, Anorectal Disorders, Sphincter Spasm
- Keywords
- Anal fissure treatment, Glyceryl Trinitrate (GTN), Nifedipine ointment, Randomized controlled trial (RCT), Pain relief in anal fissures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hafiz Muhammad HamzaUniversity, hospital or other
- Collaborators
- Federal Government Polyclinic (Postgraduate Medical Institute)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: GTN 0.2% | Active comparator | Drug: Glyceryl Trinitrate (GTN) 0.2% OintmentParticipants 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. |
| Arm 2: GTN 0.4% | Active comparator | Drug: Glyceryl Trinitrate (GTN) 0.4% OintmentParticipants 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 |
| Arm 3: Nifedipine 0.2% | Active comparator | Drug: Nifedipine 0.2% OintmentParticipants 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. |
| Arm 4: Nifedipine 0.5% | Active comparator | Drug: Nifedipine 0.5% OintmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glyceryl Trinitrate (GTN) 0.2% OintmentAlso: GTN 0.2%, Nitroglycerin 0.2% OintmentParticipants 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. | Drug | Arm 1: GTN 0.2% |
| Glyceryl Trinitrate (GTN) 0.4% OintmentAlso: GTN 0.4%, Nitroglycerin 0.4% OintmentParticipants 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. | Drug | Arm 2: GTN 0.4% |
| Nifedipine 0.2% OintmentAlso: Nifedipine Gel 0.2%, Nifedipine 0.2%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. | Drug | Arm 3: Nifedipine 0.2% |
| Nifedipine 0.5% OintmentAlso: Nifedipine Gel 0.5%, Nifedipine 0.5%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. | Drug | Arm 4: Nifedipine 0.5% |
Primary outcome
Healing Rate at 4 Weeks
Time frame: 4 weeks
The proportion of participants achieving complete epithelialization of the anal fissure on clinical examination at the end of four weeks.
4 secondary outcomes
Change in Pain Scores (Visual Analog Scale [VAS])
Time frame: 4 weeks
Incidence and Severity of Adverse Effects
Time frame: 4 weeks
Patient Satisfaction with Treatment ( Self-validated Patient Satisfaction Score)
Time frame: 4 weeks
Time to Symptom Resolution
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Results publication: PubMed 16612915Mustafa NA, Cengiz S, Turkyilmaz S, Yucel Y. Comparison of topical glyceryl trinitrate ointment and oral nifedipine in the treatment of chronic anal fissure. Acta Chir Belg. 2006 Jan-Feb;106(1):55-8. doi: 10.1080/00015458.2006.11679834.
- Results publication: PubMed 39878173Wang C, Ni J, Xiong Y, Chen J, Li B, Xu L. The efficacy of diltiazem, glyceryl trinitrate, nifedipine, minoxidil, and lidocaine for the medical management of anal fissure: a systematic review and network meta-analysis of randomized controlled trials. Int J Surg. 2025 Apr 1;111(4):3020-3029. doi: 10.1097/JS9.0000000000002263.
- Results publication: PubMed 37546514Momayez Sanat Z, Mohammadi Ganjaroudi N, Mansouri M. The Effect of Topical Nifedipine versus Diltiazem on the Acute Anal Fissure: A Randomized Clinical Trial. Middle East J Dig Dis. 2023 Apr;15(2):121-125. doi: 10.34172/mejdd.2023.330. Epub 2023 Apr 30.
- Results publication: PubMed 28598453Shrestha SK, Thapa PB, Maharjan DK, Tamang TY. Effectiveness of 0.2% Glyceryl Trinitrate and 0.5% Nifedipine in the Treatment of Chronic Anal Fissure. JNMA J Nepal Med Assoc. 2017 Jan-Mar;56(205):149-152.
- FDA Approves GTN for Chronic Anal Fissure PainLink provided by the sponsor.
- Nifedipine 0.2% ointment is a topical calcium channel blocker used for anal fissure treatment, including in diabetic patients, by relaxing the anal sphincter and increasing blood flow. It is compounded with white petrolatum and has a USP beyond-use dateLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this stage, no final decision has been made regarding the sharing of individual participant data (IPD). Data sharing will be considered based on future research needs, ethical guidelines, and institutional policies. Any decision to share IPD will be made in compliance with data protection regulations and patient confidentiality standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveed Ullah Khan, Consultant surgery, HOD study chair
Federal Government Polyclinic (Postgraduate Medical Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glyceryl Trinitrate (GTN) 0.2% Ointment, Glyceryl Trinitrate (GTN) 0.4% Ointment and Nifedipine 0.2% Ointment in people with Acute Anal Fissure and Anal Pain, run by Hafiz Muhammad Hamza at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Rate at 4 Weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06859554, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.