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

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Forest Laboratories

Status and phase

Withdrawn
Phase 4

Conditions

Anal Fissure

Treatments

Drug: Nitroglycerin Ointment 0.4%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01920074
APT-NIT_S-PRO-M_PEDKPK1_E

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

12 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Rectiv
Experimental group
Treatment:
Drug: Nitroglycerin Ointment 0.4%

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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