Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
WithdrawnPhase 4NCT01920074
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- 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
- Conditions
- Anal Fissure
- Interventions
- Drug: Nitroglycerin Ointment 0.4%
- Sponsor
- Forest Laboratories
- Start date
- 2013-06
- Primary completion
- 2015-03
- Sex
- All
- Age range
- from 12 Years to 16 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01920074