Chronic Anal FissurePhase 3NCT01132391
Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure
A Phase 3 study testing Rectogesic® (glyceryl trinitrate 0.4% ointment) in people with Chronic Anal Fissure, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
Perianal topical nitroglycerin has been widely used as a means for avoiding surgery in patients with anal fissure. However, nitroglycerin has not been universally accepted for this application because of inconsistency of efficacy and side effects. Recent studies (Dis Colon Rectum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- Rectogesic® (glyceryl trinitrate 0.4% ointment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Jun 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before a definitive definition of chronic anal fissure and ensuring inclusion in the study, all patients diagnosed as having chronic anal fissure based on their medical history and physical exploration were treated for a minimum of six weeks with conservative medical treatment (high residue diet, analgesics, and warm sitz baths). Chronic anal fissure was defined by the presence of a fibrous induration or exposed internal sphincter fibres.
Who cannot join
- Associated anal pathologies (incontinence, stenosis, abscess, fistula and haemorrhoids)
- Patients with associated conditions (inflammatory bowel disease, acquired immunodeficiency syndrome, tuberculosis, sexually transmitted disease and immunosuppression)
- Cardiopathy
- Headache and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perianal vs Endoanal Application of Glyceryl Trinitrate 0.4% Ointment in the Treatment of Chronic Anal Fissure: Results of a Randomized Controlled Trial.
Perianal topical nitroglycerin has been widely used as a means for avoiding surgery in patients with anal fissure. However, nitroglycerin has not been universally accepted for this application because of inconsistency of efficacy and side effects. Recent studies (Dis Colon Rectum. 2007 Apr;50(4):509-16) have demonstrated that nitroglycerin ointment products compounded by pharmacies did not meet the USP specifications for potency and/or content uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results raise significant issues as to whether the patient is put at undue risk relative to the relief of their anal fissure pain. In addition, one study (Dis Colon Rectum. 2006 Jun;49(6):865-8) has demonstrated that intra-anal dosing of topical nitroglycerin produces a significantly greater reduction in sphincteric pressure and lower incidence of headaches than with perianal administration of the same dose of ointment.
Topical glyceryl trinitrate 0.4% ointment has been developed and tested in clinical trials and is effective in healing chronic anal fissures. It assures exactly dose and concentration of nitroglycerin.
Read more
Hypothesis: The endoanal application of exactly dose and concentration of nitroglycerin must reduced headache and the final recurrence.
The purpose of this study is:
- Principal end-point: to compare perianal vs endoanal application of Rectogesic and evaluate the different morbidity of the two presentation
Read the detailed description
inclusion criteria: chronic anal fissure. Outcome measures: recurrence and headache.
- Conditions
- Chronic Anal Fissure
- Being tested
- Rectogesic® (glyceryl trinitrate 0.4% ointment)
- Keywords
- anal fissure, nitroglycerin, medical treatment
- 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.
Rectogesic® (glyceryl trinitrate 0.4% ointment)Drug
375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Endoanal application Receives: Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment) |
| 2 | Experimental | Perianal application Receives: Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache (during eights weeks of treatment)
Measured: Visual analogical Score
Secondary outcomes (1)
Recurrence or persistence anal fissure (six month)
Measured: Yes/No
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Investigators
- Antonio Arroyo, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132391
- Sponsor's protocol ID
- FAC
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez-Legaz J, Arroyo A, Moya P, Ruiz-Tovar J, Frangi A, Candela F, Oliver MI, Calpena R. Perianal versus endoanal application of glyceryl trinitrate 0.4% ointment in the treatment of chronic anal fissure: results of a randomized controlled trial. Is this the solution to the headaches? Dis Colon Rectum. 2012 Aug;55(8):893-9. doi: 10.1097/DCR.0b013e31825a9f1f.
PubMed 22810476
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perianal vs Endoanal Application of Glyceryl Trinitrate 0.4% Ointment in the Treatment of Chronic Anal Fissure: Results of a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01132391
- Acronym / sponsor ID
- FAC
- Conditions
- Chronic Anal Fissure
- Keywords
- anal fissure, nitroglycerin, medical treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 May 2010 (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.
Perianal topical nitroglycerin has been widely used as a means for avoiding surgery in patients with anal fissure. However, nitroglycerin has not been universally accepted for this application because of inconsistency of efficacy and side effects. Recent studies (Dis Colon Rectum. 2007 Apr;50(4):509-16) have demonstrated that nitroglycerin ointment products compounded by pharmacies did not meet the USP specifications for potency and/or content uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results raise significant issues as to whether the patient is put at undue risk relative to the relief of their anal fissure pain. In addition, one study (Dis Colon Rectum. 2006 Jun;49(6):865-8) has demonstrated that intra-anal dosing of topical nitroglycerin produces a significantly greater reduction in sphincteric pressure and lower incidence of headaches than with perianal administration of the same dose of ointment.
Topical glyceryl trinitrate 0.4% ointment has been developed and tested in clinical trials and is effective in healing chronic anal fissures. It assures exactly dose and concentration of nitroglycerin.
Hypothesis: The endoanal application of exactly dose and concentration of nitroglycerin must reduced headache and the final recurrence.
The purpose of this study is:
- Principal end-point: to compare perianal vs endoanal application of Rectogesic and evaluate the different morbidity of the two presentation
Detailed description
inclusion criteria: chronic anal fissure. Outcome measures: recurrence and headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)Endoanal application |
| 2 | Experimental | Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)Perianal application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Before a definitive definition of chronic anal fissure and ensuring inclusion in the study, all patients diagnosed as having chronic anal fissure based on their medical history and physical exploration were treated for a minimum of six weeks with conservative medical treatment (high residue diet, analgesics, and warm sitz baths). Chronic anal fissure was defined by the presence of a fibrous induration or exposed internal sphincter fibres.
Key exclusion criteria (4 listed)
- Associated anal pathologies (incontinence, stenosis, abscess, fistula and haemorrhoids)
- Patients with associated conditions (inflammatory bowel disease, acquired immunodeficiency syndrome, tuberculosis, sexually transmitted disease and immunosuppression)
- Cardiopathy
- Headache and pregnancy.
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 |
|---|---|---|
| Rectogesic® (glyceryl trinitrate 0.4% ointment)375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS | Drug | 1, 2 |
Primary outcome
Headache (during eights weeks of treatment)
Time frame: Visual analogical Score
1 secondary outcome
Recurrence or persistence anal fissure (six month)
Time frame: Yes/No
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
- Derived from this study: PubMed 22810476Perez-Legaz J, Arroyo A, Moya P, Ruiz-Tovar J, Frangi A, Candela F, Oliver MI, Calpena R. Perianal versus endoanal application of glyceryl trinitrate 0.4% ointment in the treatment of chronic anal fissure: results of a randomized controlled trial. Is this the solution to the headaches? Dis Colon Rectum. 2012 Aug;55(8):893-9. doi: 10.1097/DCR.0b013e31825a9f1f.
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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.
Antonio Arroyo, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rectogesic® (glyceryl trinitrate 0.4% ointment) in people with Chronic Anal Fissure, run by Hospital General Universitario Elche at 1 site in Spain.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Headache (during eights weeks of treatment) (time frame: Visual analogical Score). 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 NCT01132391, which also lists 1 linked publication.
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 28 May 2010.