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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132391
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : May 28, 2010
Information provided by:
Hospital General Universitario Elche

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Chronic Anal Fissure Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment) Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perianal vs Endoanal Application of Glyceryl Trinitrate 0.4% Ointment in the Treatment of Chronic Anal Fissure: Results of a Randomized Controlled Trial.
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Endoanal application
Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)
375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS

Experimental: 2
Perianal application
Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)
375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS

Primary Outcome Measures :
  1. Headache (during eights weeks of treatment) [ Time Frame: Visual analogical Score ]

Secondary Outcome Measures :
  1. Recurrence or persistence anal fissure (six month) [ Time Frame: Yes/No ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132391

Coloproctology Unit. Elche Hospital
Elche, Alicante, Spain, 03203
Sponsors and Collaborators
Hospital General Universitario Elche
Principal Investigator: Antonio Arroyo, PhD

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr.Antonio Arroyo Sebastian, Coloproctology Unit. University Hospital of Elche Identifier: NCT01132391     History of Changes
Other Study ID Numbers: FAC
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: May 28, 2010
Last Verified: September 2009

Keywords provided by Hospital General Universitario Elche:
anal fissure
medical treatment

Additional relevant MeSH terms:
Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vasodilator Agents