Anal FissurePhase 4NCT00827736
Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure
A Phase 4 study testing Botox and ISDN ointment in people with Anal Fissure, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial summary
The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fissure
- What is being tested?
- Botox and ISDN ointment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2002to Mar 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic
Who cannot join
- pregnancy
- previous anal surgery
- Crohn's disease
- systemic causes of an anal fissure
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 HM
About this study
Official title: Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial
The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.
- Conditions
- Anal Fissure
- Being tested
- Botox, ISDN ointment, Placebo
- Keywords
- anal fissure, fissura ani, botox, ISDN, Nitric oxide donor
- 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.
BotoxProcedure or surgery
injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
ISDN ointmentDrug
application of ISDN 1% ointment 6 times a day
PlaceboDrug
Injection of placebo into internal anal sphincter (ISDN ointment arm)
Applied to the anoderm six times a day (Botox injection arm)
| Study group | Role | What they receive |
|---|---|---|
| Botox injection | Experimental | injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline. In addition, a placebo ointment has to be applied to the anoderm six times a day Receives: Procedure: Botox |
| ISDN ointment | Active comparator | application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter Receives: Procedure: Botox; Drug: ISDN ointment; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
macroscopic healing of the fissure
Measured: 4 months
Secondary outcomes (4)
complications
Measured: 12 months
fissure recurrence
Measured: 12 months
fissure related pain
Measured: 12 months
costs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJun 2002
- Primary completionMar 2006
- Study completionMar 2006
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Investigators
- Michael Gerhards, MD, Study director, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827736
- Sponsor's protocol ID
- 00.058
- Status last verified
- Jan 2009
- First submitted
- 20 Jan 2009
- Last updated
- 23 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Brisinda G, Maria G, Bentivoglio AR, Cassetta E, Gui D, Albanese A. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med. 1999 Jul 8;341(2):65-9. doi: 10.1056/NEJM199907083410201.
PubMed 10395629
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT00827736
- Acronym / sponsor ID
- 00.058
- Conditions
- Anal Fissure
- Keywords
- anal fissure, fissura ani, botox, ISDN, Nitric oxide donor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 23 Jan 2009 (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.
The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox injection | Experimental | Procedure: Botoxinjection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline. In addition, a placebo ointment has to be applied to the anoderm six times a day |
| ISDN ointment | Active comparator | Procedure: Botox, Drug: ISDN ointment, Drug: Placeboapplication of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic
Key exclusion criteria (4 listed)
- pregnancy
- previous anal surgery
- Crohn's disease
- systemic causes of an anal fissure
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 |
|---|---|---|
| Botoxinjection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline. | Procedure or surgery | Botox injection, ISDN ointment |
| ISDN ointmentapplication of ISDN 1% ointment 6 times a day | Drug | ISDN ointment |
| PlaceboInjection of placebo into internal anal sphincter (ISDN ointment arm) Applied to the anoderm six times a day (Botox injection arm) | Drug | ISDN ointment |
Primary outcome
macroscopic healing of the fissure
Time frame: 4 months
4 secondary outcomes
complications
Time frame: 12 months
fissure recurrence
Time frame: 12 months
fissure related pain
Time frame: 12 months
costs
Time frame: 12 months
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 23 Jan 2009.
- Results publication: PubMed 10395629Brisinda G, Maria G, Bentivoglio AR, Cassetta E, Gui D, Albanese A. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med. 1999 Jul 8;341(2):65-9. doi: 10.1056/NEJM199907083410201.
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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.
Michael Gerhards, MD study director
Onze Lieve Vrouwe Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botox and ISDN ointment in people with Anal Fissure, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
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 23 Jan 2009. 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 Netherlands. 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 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?
macroscopic healing of the fissure (time frame: 4 months). 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 NCT00827736, 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 23 Jan 2009.