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

This study has been completed.
Sponsor:
Information provided by:
Hospital General Universitario Elche
ClinicalTrials.gov Identifier:
NCT01132391
First received: September 8, 2009
Last updated: May 27, 2010
Last verified: September 2009
  Purpose

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 Intervention Phase
Chronic Anal Fissure
Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hospital General Universitario Elche:

Primary Outcome Measures:
  • Headache (during eights weeks of treatment) [ Time Frame: Visual analogical Score ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence or persistence anal fissure (six month) [ Time Frame: Yes/No ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01132391

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

No publications provided by Hospital General Universitario Elche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.Antonio Arroyo Sebastian, Coloproctology Unit. University Hospital of Elche
ClinicalTrials.gov Identifier: NCT01132391     History of Changes
Other Study ID Numbers: FAC
Study First Received: September 8, 2009
Last Updated: May 27, 2010
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014