Application of Vitamin E on Anal Fissure

NCT03787030 | Completed Phase 3 DMC

• 1 other identifier: Garcia 2018-12
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Patients were randomized into 2 groups:

• Vitamin E: Vitamin E ointment will be applied during 8 weeks
• Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and subjects patients receiving Vitamin E ointment were evaluated .

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain associated to anal fissure: Visual Analogic Scale

  Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)

  8 weeks

Secondary Outcomes (1)

• Number of participants achieving the healing of the fissure

  8 weeks

Study Arms (2)

Vitamin E acetate

EXPERIMENTAL

Commercially available plastic tubes containing vitamin E acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml of ointment (containing 1100% vitamin E), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Drug: Vitamin E Acetate ointment

Glyceryl trinitrate ointment

ACTIVE COMPARATOR

Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Drug: Glyceryl trinitrate ointment

Interventions

Vitamin E Acetate ointment DRUG

Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.

Vitamin E acetate

Glyceryl trinitrate ointment DRUG

Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.

Glyceryl trinitrate ointment

Eligibility Criteria

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

You may qualify if:

• Patients with diagnosis of chronic anal fissure

You may not qualify if:

• patients with associated anal pathologies
• intestinal inflammation disorders
• immunosuppression
• fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases)
• patients with a history of headaches, heart disease, or intolerance to nitrates
• pregnant or lactating women
• patients with closed angle glaucoma

Sponsors & Collaborators

• Hospital General Universitario Elche: lead

Study Sites (1)

Garcilaso Clinic

Madrid, 28010, Spain

Location

Related Publications (1)

• Ruiz-Tovar J, Llavero C. Perianal Application of Glyceryl Trinitrate Ointment Versus Tocopherol Acetate Ointment in the Treatment of Chronic Anal Fissure: A Randomized Clinical Trial. Dis Colon Rectum. 2022 Mar 1;65(3):406-412. doi: 10.1097/DCR.0000000000002120.

  PMID: 34803148 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolina Llavero

  Garcilaso Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Surgery

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: December 21, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

ES (1)