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Fissure in Ano clinical trials

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NCT ID: NCT01132391 Completed - Clinical trials for Chronic Anal Fissure

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

Start date: January 2009
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT00972907 Completed - Clinical trials for Chronic Anal Fissure

An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects

Start date: December 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label study. The study will consist of 1 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine, administered BID to subjects with chronic anal fissure.

NCT ID: NCT00827736 Completed - Anal Fissure Clinical Trials

Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure

Start date: June 2002
Phase: Phase 4
Study type: Interventional

The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.

NCT ID: NCT00522041 Completed - Pain Clinical Trials

A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures

Start date: August 2007
Phase: Phase 3
Study type: Interventional

Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially upon defecation and for one or two hours afterwards. There are no approved drugs in the US for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe. To determine the effect of Cellegesic versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.

NCT ID: NCT00210444 Completed - Anal Fissure Clinical Trials

Efficacy Study of Dysport® in the Treatment of Anal Fissure.

Start date: June 2003
Phase: Phase 2
Study type: Interventional

To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug