MedDataX Logo

Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure

NCT ID: NCT01132391

Last Updated: 2010-05-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Perianal topical nitroglycerin has been widely used as a means for avoiding surgery in patients with anal fissure. However, nitroglycerin has not been universally accepted for this application because of inconsistency of efficacy and side effects. Recent studies (Dis Colon Rectum. 2007 Apr;50(4):509-16) have demonstrated that nitroglycerin ointment products compounded by pharmacies did not meet the USP specifications for potency and/or content uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results raise significant issues as to whether the patient is put at undue risk relative to the relief of their anal fissure pain. In addition, one study (Dis Colon Rectum. 2006 Jun;49(6):865-8) has demonstrated that intra-anal dosing of topical nitroglycerin produces a significantly greater reduction in sphincteric pressure and lower incidence of headaches than with perianal administration of the same dose of ointment.

Topical glyceryl trinitrate 0.4% ointment has been developed and tested in clinical trials and is effective in healing chronic anal fissures. It assures exactly dose and concentration of nitroglycerin.

Hypothesis: The endoanal application of exactly dose and concentration of nitroglycerin must reduced headache and the final recurrence.

The purpose of this study is:

1\. Principal end-point: to compare perianal vs endoanal application of Rectogesic and evaluate the different morbidity of the two presentation

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

inclusion criteria: chronic anal fissure. Outcome measures: recurrence and headache.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Anal Fissure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

anal fissure nitroglycerin medical treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Endoanal application

Group Type EXPERIMENTAL

Rectogesic® (glyceryl trinitrate 0.4% ointment)

Intervention Type DRUG

375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS

2

Perianal application

Group Type EXPERIMENTAL

Rectogesic® (glyceryl trinitrate 0.4% ointment)

Intervention Type DRUG

375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rectogesic® (glyceryl trinitrate 0.4% ointment)

375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Before a definitive definition of chronic anal fissure and ensuring inclusion in the study, all patients diagnosed as having chronic anal fissure based on their medical history and physical exploration were treated for a minimum of six weeks with conservative medical treatment (high residue diet, analgesics, and warm sitz baths). Chronic anal fissure was defined by the presence of a fibrous induration or exposed internal sphincter fibres.

Exclusion Criteria

* Associated anal pathologies (incontinence, stenosis, abscess, fistula and haemorrhoids)
* Patients with associated conditions (inflammatory bowel disease, acquired immunodeficiency syndrome, tuberculosis, sexually transmitted disease and immunosuppression)
* Cardiopathy
* Headache and pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Coloproctology Unit. University Hospital of Elche

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antonio Arroyo, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Coloproctology Unit. Elche Hospital

Elche, Alicante, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Perez-Legaz J, Arroyo A, Moya P, Ruiz-Tovar J, Frangi A, Candela F, Oliver MI, Calpena R. Perianal versus endoanal application of glyceryl trinitrate 0.4% ointment in the treatment of chronic anal fissure: results of a randomized controlled trial. Is this the solution to the headaches? Dis Colon Rectum. 2012 Aug;55(8):893-9. doi: 10.1097/DCR.0b013e31825a9f1f.

Reference Type DERIVED
PMID: 22810476 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FAC

Identifier Type: -

Identifier Source: org_study_id