Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
NCT ID: NCT01920074
Last Updated: 2015-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2013-06-30
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
NCT00522041
Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure
NCT01132391
Glyceryl Trinitrate Ointment vs Posterior Tibial Nerve Stimulation in the Treatment of Anal Fissure
NCT02700438
Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure
NCT04604483
Efficacy and Safety of GTN vs. Nifedipine in Acute Anal Fissure: A Clinical Trial
NCT06859554
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rectiv
Nitroglycerin Ointment 0.4%
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nitroglycerin Ointment 0.4%
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
12 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Forest Laboratories
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul Hyman, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital New Orleans, LA
Taryn Weissman, MD
Role: STUDY_DIRECTOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital
Los Angeles, California, United States
Advanced Medical Research Center
Miami, Florida, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Willis-Knighton Pediatric GI Specialist
Shreveport, Louisiana, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Sealy Urgent Care Center and Medical Clinic
Sealy, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Demirbag S, Tander B, Atabek C, Surer I, Ozturk H, Cetinkursun S. Long-term results of topical glyceryl trinitrate ointment in children with anal fissure. Ann Trop Paediatr. 2005 Jun;25(2):135-7. doi: 10.1179/146532805X45737.
Kenny SE, Irvine T, Driver CP, Nunn AT, Losty PD, Jones MO, Turnock RR, Lamont GL, Lloyd DA. Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure. Arch Dis Child. 2001 Nov;85(5):404-7. doi: 10.1136/adc.85.5.404.
Schiano di Visconte M, Di Bella R, Munegato G. Randomized, prospective trial comparing 0.25 percent glycerin trinitrate ointment and anal cryothermal dilators only with 0.25 percent glycerin trinitrate ointment and only with anal cryothermal dilators in the treatment of chronic anal fissure: a two-year follow-up. Dis Colon Rectum. 2006 Dec;49(12):1822-30. doi: 10.1007/s10350-006-0731-y.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APT-NIT_S-PRO-M_PEDKPK1_E
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.