Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure

A Phase 4, Multiple-dose, Pharmacokinetic, Safety, and Exploratory Efficacy Study of Nitroglycerin Ointment 0.4% (RECTIV®) in Adolescents (Age ≥12 to <17 Years) With Moderate to Severe Pain Due to Chronic Anal Fissure

RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to severe pain associated with chronic anal fissure approved in June 2011 by the US Food and Drug Administration (FDA) for adults. The purpose of this study is to assess the safety, pharmacokinetics, and exploratory efficacy of RECTIV® in adolescents

This is an open-label, multicenter study conducted in up to 10 sites in the United States. A total of 13 pediatric male or female patients age ≥12 to <17 years will be enrolled. The patients will administer a dose of Rectiv® twice daily to characterize the safety, pharmacokinetics , and exploratory efficacy of Nitroglycerin Ointment 0.4% (RECTIV® )over 5 days

Key Inclusion Criteria:

• Male or female ≥12 and <17 years of age
• At least 1 anal fissure for a minimum of 3 weeks in duration
• Anal fissure pain experienced over the last 24 hours at Screening and before enrollment
• Patient (and parent or caregiver as appropriate) has provided written informed consent

Key Exclusion Criteria:

• Current diagnosis of hemorrhoids
• Hypersensitivity, allergy, or contraindication to nitroglycerin
• History of hypertension and/or cardiovascular disease
• History or current diagnosis of inflammatory bowel disease
• History or current diagnosis of fistula(e)-in-ano or an anal abscess
• Fibrotic anal stenosis
• Previous anal surgery
• Diagnosis of cancer
• History of migraine or chronic headaches requiring treatment with analgesics
• Pregnant or lactating female patients
• Weight <36 kg