Contact information
Type
Scientific
Primary contact
Dr W.F. Tets
ORCID ID
Contact details
Sint Lucas Andreas Ziekenhuis
Department Surgery
P.O. Box 9243
Amsterdam
1006 AE
Netherlands
w.vantets@slaz.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR441; 2004/149
Study information
Scientific title
Acronym
Study hypothesis
Treatment of anal fissure with isosorbide dinitrate (ISDN) or Botulinum toxin A gives approximately comparative outcomes. Because of intensive treatment with isosorbide dinitrate cream, patients treated with Botulinum toxin A will be more satisfied. After six weeks treatment with Botulinum toxin A, the patient satisfaction will be significant more than patients treated with isosorbide dinitrate.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised single blind active controlled parallel trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Anal fissure
Intervention
ISDN 1% cream versus Botuline Toxine A for a duration of 12 weeks.
ISDN cream application every 4 hours for 12 weeks.
Botulinum Toxin A injection at week 0 and if necessary again at week 6.
Botulinum Toxin A Dysport® is made by Ipsen.
Intervention type
Drug
Phase
Not Specified
Drug names
Botulinum toxin A (Dysport®), isosorbide dinitrate
Primary outcome measure
1. Patient satisfaction after 6 weeks
2. Visual Analogue Score on weeks 0, 6 and 12
Secondary outcome measures
1. Patient satisfaction after 12 weeks
2. Pain after defecation at night
3. Incontinence after 6 and 12 weeks
4. Healing of fissure after 6 and 12 weeks
Overall trial start date
08/11/2004
Overall trial end date
01/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosed anal fissure with complaints
2. Complaints longer than 2 months
3. Age 21-60 years
4. Dutch speaking
5. Will-competent
6. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Pregnancy, lactation
2. Muscle-sicknesses such as myasthenia gravis
3. Simultaneous use of medication interacting with neuromuscular transmission
4. Fistulas
5. Coagulation disorders or the use of anticoagulants
6. Anal surgery in the past
7. Haemorrhoids or inflammatory bowel sicknesses as a cause of anal fissure
8. Major secondary changes because of the anal fissure
Recruitment start date
08/11/2004
Recruitment end date
01/07/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Sint Lucas Andreas Ziekenhuis
Amsterdam
1006 AE
Netherlands
Sponsor information
Organisation
Ipsen Farmaceutica B.V. (Netherlands)
Sponsor details
Hoofdweg Oostzijde 620
Hoofddorp
2132 MJ
Netherlands
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
Ipsen Farmaceutica B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list