Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure
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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. |
- Headache (during eights weeks of treatment) [ Time Frame: Visual analogical Score ] [ Designated as safety issue: Yes ]
- 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 |
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 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 May 16, 2013