Anal Fissure
Conditions
Keywords
Anal Fissure, Nitroglycerin, Pediatrics, RECTIV®, Pediatric Research Equity Act
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
Interventions
DRUGNitroglycerin Ointment 0.4%
Sponsors
Forest Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 5 | The following PK parameters will be calculated as data permit: * Maximum observed concentration (Cmax) * Time of the maximum observed plasma concentration (Tmax) * Area under the concentration time curve from dosing up to the last quantifiable concentration (AUC0-last). * Area under the concentration time curve from dosing up to 480 minutes (AUC0-480) * The extrapolated area under the concentration time curve from dosing up to 12 hours (AUC0-12h) also will be calculated if quantifiable concentrations are observed during the entire dose interval. * Terminal elimination half-life (t1/2) On the basis of the results of the study, additional noncompartmental PK parameters may be calculated and reported. In addition, a population PK model for NTG will be developed based on the PK data from Day 5. By using this model, the following additional PK parameters may be reported: * Apparent volume of distribution (V/F) * Apparent clearance (CL/F) |
Secondary
| Measure | Time frame |
|---|---|
| • 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 | Day 5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety of Rectiv® in adolescents (age ≥12 to <17 years) | Screening through the completion of study participation | Safety and tolerability are assessed through adverse events (AEs), clinical laboratory test results (hematology, serum biochemistry, and urinalysis), vital sign measurements (heart rate, supine and orthostatic blood pressure, oral temperature, and respiratory rate), 12-lead ECG results, anal area assessment, physical examination findings (including body weight), and concomitant medications (including the use of rescue acetaminophen for headaches). |
Countries
United States
Outcome results
None listed