Clinical trial NCT01920074: Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anal Fissure
Keywords: Anal Fissure
Nitroglycerin
Pediatrics
RECTIV®
Pediatric Research Equity Act
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2013-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Administration (FDA) for adults. The purpose of this study is to assess the safety, pharmacokinetics, and exploratory efficacy of RECTIV® in adolescents

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 administer a dose of Rectiv® twice daily to characterize the safety, pharmacokinetics , and exploratory efficacy of Nitroglycerin Ointment 0.4% (RECTIV® )over 5 days

Eligibility 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

Primary outcomes:
measure: Noncompartmental pharmacokinetic (PK) analyses will be performed on the full pharmacokinetic curves for NTG and its metabolites (1,2 glyceryl dinitrate and 1,3 glyceryl dinitrate) on Day 5
timeFrame: Day 5
Secondary outcomes:
measure: • Absolute change from baseline in 24-hour average anal fissure pain scores assessed by the Wong-Baker FACES® and the Numerical Rating Scale for pain after each evening dose over days 1 through 4
timeFrame: Day 5
Other outcomes:
measure: To assess the safety of Rectiv® in adolescents (age ≥12 to <17 years)
timeFrame: Screening through the completion of study participation
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital
state: California
city: Miami
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Shreveport
country: United States
facility: Willis-Knighton Pediatric GI Specialist
state: Louisiana
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Sealy
country: United States
facility: Sealy Urgent Care Center and Medical Clinic
state: Texas
Study officials:
affiliation: Children's Hospital New Orleans, LA
name: Paul Hyman, MD
role: PRINCIPAL_INVESTIGATOR
name: Taryn Weissman, MD
role: STUDY_DIRECTOR
References:
citation: Demirbag S, Tander B, Atabek C, Surer I, Ozturk H, Cetinkursun S. Long-term results of topical glyceryl trinitrate ointment in children with anal fissure. Ann Trop Paediatr. 2005 Jun;25(2):135-7. doi: 10.1179/146532805X45737.
citation: Kenny SE, Irvine T, Driver CP, Nunn AT, Losty PD, Jones MO, Turnock RR, Lamont GL, Lloyd DA. Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure. Arch Dis Child. 2001 Nov;85(5):404-7. doi: 10.1136/adc.85.5.404.
citation: Schiano di Visconte M, Di Bella R, Munegato G. Randomized, prospective trial comparing 0.25 percent glycerin trinitrate ointment and anal cryothermal dilators only with 0.25 percent glycerin trinitrate ointment and only with anal cryothermal dilators in the treatment of chronic anal fissure: a two-year follow-up. Dis Colon Rectum. 2006 Dec;49(12):1822-30. doi: 10.1007/s10350-006-0731-y.