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

• Status: Withdrawn
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Nitroglycerin

Criteria

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