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

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ClinicalTrials.gov Identifier: NCT01920074
Recruitment Status : Withdrawn (Study stopped due to study enrollment challenges that impacted the feasibility of conducting the study.)
First Posted : August 9, 2013
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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

Condition or disease Intervention/treatment Phase
Anal Fissure Drug: Nitroglycerin Ointment 0.4% Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rectiv Drug: Nitroglycerin Ointment 0.4%



Primary Outcome Measures :
  1. 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 [ Time Frame: 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 Outcome Measures :
  1. • 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 [ Time Frame: Day 5 ]

Other Outcome Measures:
  1. To assess the safety of Rectiv® in adolescents (age ≥12 to <17 years) [ Time Frame: 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).



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920074


Locations
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United States, California
Children's Hospital
Los Angeles, California, United States, 90027
United States, Florida
Advanced Medical Research Center
Miami, Florida, United States, 33135
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
United States, Louisiana
Willis-Knighton Pediatric GI Specialist
Shreveport, Louisiana, United States, 71118
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Texas
Sealy Urgent Care Center and Medical Clinic
Sealy, Texas, United States, 77474
Sponsors and Collaborators
Forest Laboratories
Investigators
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Principal Investigator: Paul Hyman, MD Children's Hospital New Orleans, LA
Study Director: Taryn Weissman, MD

Publications of Results:
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01920074     History of Changes
Other Study ID Numbers: APT-NIT_S-PRO-M_PEDKPK1_E
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: May 2015

Keywords provided by Forest Laboratories:
Anal Fissure
Nitroglycerin
Pediatrics
RECTIV®
Pediatric Research Equity Act

Additional relevant MeSH terms:
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Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nitroglycerin
Vasodilator Agents