Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
Public ClinicalTrials.gov record NCT01920074. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01920074
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2013 (Type not available)
- Primary completion
- Mar 2015 (Actual)
- Completion
- Apr 2015 (Actual)
- Last update posted
- May 4, 2015
2013 – 2015
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital | Los Angeles | California | 90027 | — |
| Advanced Medical Research Center | Miami | Florida | 33135 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| Willis-Knighton Pediatric GI Specialist | Shreveport | Louisiana | 71118 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Sealy Urgent Care Center and Medical Clinic | Sealy | Texas | 77474 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01920074, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 4, 2015 · Synced Nov 11, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01920074 live on ClinicalTrials.gov.