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

NCT01132391 | Completed Phase 3

• 1 other identifier: FAC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Anal Fissure

Keywords

anal fissure; nitroglycerin; medical treatment

Outcome Measures

Primary Outcomes (1)

• Headache (during eights weeks of treatment)

  Visual analogical Score

Secondary Outcomes (1)

• Recurrence or persistence anal fissure (six month)

  Yes/No

Study Arms (2)

1

EXPERIMENTAL

Endoanal application

Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)

2

EXPERIMENTAL

Perianal application

Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)

Interventions

Rectogesic® (glyceryl trinitrate 0.4% ointment) DRUG

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

1; 2

Eligibility Criteria

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario Elche: lead

Study Sites (1)

Coloproctology Unit. Elche Hospital

Elche, Alicante, 03203, Spain

Location

Related Publications (1)

• 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.

  PMID: 22810476 DERIVED

MeSH Terms

Conditions

Fissure in Ano

Interventions

Nitroglycerin; Ointments

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Antonio Arroyo, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: May 28, 2010
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 28, 2010

Record last verified: 2009-09

Locations

ES (1)