Overview

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

Status:
Withdrawn
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Forest Laboratories
Treatments:
Nitroglycerin