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

2014-08-27 03:36:29 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Fissure in Ano

Intervention

nitroglycerin 0.4%, Placebo

Status

Completed

Source

Prostrakan Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:36:29-0400

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Medical and Biotech [MESH] Definitions

Surgical incision of the INTERNAL ANAL SPHINCTER typically in the treatment of FISSURE IN ANO; chronic ANAL FISSURE and FECAL INCONTINENCE.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

A vasodilator used in the treatment of ANGINA PECTORIS. Its actions are similar to NITROGLYCERIN but with a slower onset of action.

A vasodilator with general properties similar to NITROGLYCERIN. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1020)

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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