Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure
NCT ID: NCT00827736
Last Updated: 2009-01-23
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
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COMPLETED
PHASE4
73 participants
INTERVENTIONAL
2002-06-30
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Botox injection
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
Botox
injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
ISDN ointment
application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter
Botox
injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
ISDN ointment
application of ISDN 1% ointment 6 times a day
Placebo
Injection of placebo into internal anal sphincter (ISDN ointment arm)
Applied to the anoderm six times a day (Botox injection arm)
Interventions
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Botox
injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
ISDN ointment
application of ISDN 1% ointment 6 times a day
Placebo
Injection of placebo into internal anal sphincter (ISDN ointment arm)
Applied to the anoderm six times a day (Botox injection arm)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* previous anal surgery
* Crohn's disease
* systemic causes of an anal fissure
18 Years
ALL
No
Sponsors
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Onze Lieve Vrouwe Gasthuis
OTHER
Responsible Party
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Onze Lieve Vrouwe Gasthuis
Principal Investigators
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Michael Gerhards, MD
Role: STUDY_DIRECTOR
Onze Lieve Vrouwe Gasthuis
Locations
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Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands
Countries
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References
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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.
Other Identifiers
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00.058
Identifier Type: -
Identifier Source: org_study_id
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