Anal FissurePhase 4NCT01920074
Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
A Phase 4 study testing Nitroglycerin Ointment 0.4% in people with Anal Fissure, run by Forest Laboratories at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Anal Fissure
- What is being tested?
- Nitroglycerin Ointment 0.4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2013to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital
Los Angeles, California, 90027
Advanced Medical Research Center
Miami, Florida, 33135
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Sealy Urgent Care Center and Medical Clinic
Sealy, Texas, 77474
Willis-Knighton Pediatric GI Specialist
Shreveport, Louisiana, 71118
About this study
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
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
Read the 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
- Conditions
- Anal Fissure
- Being tested
- Nitroglycerin Ointment 0.4%
- Keywords
- Anal Fissure, Nitroglycerin, Pediatrics, RECTIV®, Pediatric Research Equity Act
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin Ointment 0.4%Drug
| Study group | Role | What they receive |
|---|---|---|
| Rectiv | Experimental | Not described Receives: Drug: Nitroglycerin Ointment 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Measured: Day 5
Secondary outcomes (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
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionApr 2015
Why it stopped: Study stopped due to study enrollment challenges that impacted the feasibility of conducting the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Hyman, MD, Principal investigator, Children's Hospital New Orleans, LATaryn Weissman, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920074
- Sponsor's protocol ID
- APT-NIT_S-PRO-M_PEDKPK1_E
- Status last verified
- May 2015
- First submitted
- 7 Aug 2013
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15949202Kenny 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.
PubMed 11668104Schiano 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.
PubMed 17096178
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01920074
- Acronym / sponsor ID
- APT-NIT_S-PRO-M_PEDKPK1_E
- Conditions
- Anal Fissure
- Keywords
- Anal Fissure, Nitroglycerin, Pediatrics, RECTIV®, Pediatric Research Equity Act
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to study enrollment challenges that impacted the feasibility of conducting the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectiv | Experimental | Drug: Nitroglycerin Ointment 0.4% |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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 (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerin Ointment 0.4% | Drug | Rectiv |
Primary outcome
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)
1 secondary outcome
• 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Results publication: PubMed 15949202Demirbag 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.
- Results publication: PubMed 11668104Kenny 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.
- Results publication: PubMed 17096178Schiano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Hyman, MD principal investigator
Children's Hospital New Orleans, LA
Taryn Weissman, MD study director
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitroglycerin Ointment 0.4% in people with Anal Fissure, run by Forest Laboratories at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920074, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.