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

Withdrawn before enrolling · Phase 4

Conditions studied: Anal Fissure

In brief

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

Key facts

Study ID

NCT01920074

Run by

Forest Laboratories

People needed

0

Starts

2013-06-01

Expected to finish

2015-04-01

Last updated by the study team

2015-05-04

Who can join

Age: 12 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Children's Hospital — Los Angeles, California, United States
• Advanced Medical Research Center — Miami, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Willis-Knighton Pediatric GI Specialist — Shreveport, Louisiana, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Sealy Urgent Care Center and Medical Clinic — Sealy, Texas, United States

Full record on ClinicalTrials.gov

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