Status:
WITHDRAWN
Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
Lead Sponsor:
Forest Laboratories
Conditions:
Anal Fissure
Eligibility:
All Genders
12-16 years
Phase:
PHASE4
Brief 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 Administratio...
Detailed Description
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 adm...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01920074
Start Date
June 1 2013
End Date
April 1 2015
Last Update
May 4 2015
Active Locations (6)
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1
Children's Hospital
Los Angeles, California, United States, 90027
2
Advanced Medical Research Center
Miami, Florida, United States, 33135
3
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
4
Willis-Knighton Pediatric GI Specialist
Shreveport, Louisiana, United States, 71118