Condition category
Digestive System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ipsen.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes