Anal FissurePhase 2NCT00210444
Efficacy Study of Dysport® in the Treatment of Anal Fissure.
A Phase 2 study testing Botulinum toxin type A in people with Anal Fissure, run by Ipsen at 7 sites in 4 countries.
Trial summary
To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Fissure
- What is being tested?
- Botulinum toxin type A
- How many people
- 168 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jun 2003to Dec 2006
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having idiopathic anal fissure in the posterior anal midline
- Patients having anal fissure present for less than 6 months
- Patients having symptoms (pain) present for a minimum of 2 weeks and not responding after 2 weeks of standard therapy (diet, laxatives, sitz-bathes)
Who cannot join
- Patients having anal fistulas or anal fissure of various causes such as Crohn disease, Behcet infectious ulceration, anal suppuration, subfissural infiltration, abscesses, acute haemorrhoidal attacks or inflammatory bowel disease
- Patients having idiopathic anal fissure in the anterior anal midline
- Patients having lateral or multiple fissures
- Patients having anal or perianal cancer
- Patients who underwent previous anal surgery or have cicatricial alterations or post-surgical cicatricial lesions
- Patients receiving drugs affecting neuromuscular transmission
Show all 11Show fewer
- Patients who have received topical anaesthetic within 3 days of injection
- Patients receiving local treatment by myorelaxing agent
- Patients receiving prohibited analgesics
- Patients having bleeding disturbances or currently using coumarin derivates
- Patients having myasthenia or any genetic muscle disease
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Czechia3 sites
Faculty Nemocnice-III
Brno, 639-01
Faculty Nemocnice
Hradec Králové, 500-05
Thomayer's Memorial Hospital
Prague, 140-59
Poland2 sites
Consulting Room of Proctology
Gdansk, 80-371
Medical University of Lodz
Lodz, 90-447
About this study
Official title: A Phase II, Multicentre, Open, Randomised, Parallel Group, Dose Ranging Study to Define the Efficacy of Dysport® in the Treatment of Anal Fissure.
To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug
- Conditions
- Anal Fissure
- Being tested
- Botulinum toxin type A
- 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.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
Secondary outcomes (1)
Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FissureStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210444
- Sponsor's protocol ID
- A-38-52120-714
- Status last verified
- Apr 2020
- First submitted
- 19 Sep 2005
- Last updated
- 29 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Open, Randomised, Parallel Group, Dose Ranging Study to Define the Efficacy of Dysport® in the Treatment of Anal Fissure.
- ClinicalTrials.gov ID
- NCT00210444
- Acronym / sponsor ID
- A-38-52120-714
- Conditions
- Anal Fissure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Sep 2005 (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.
To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having idiopathic anal fissure in the posterior anal midline
- Patients having anal fissure present for less than 6 months
- Patients having symptoms (pain) present for a minimum of 2 weeks and not responding after 2 weeks of standard therapy (diet, laxatives, sitz-bathes)
Key exclusion criteria (11 listed)
- Patients having anal fistulas or anal fissure of various causes such as Crohn disease, Behcet infectious ulceration, anal suppuration, subfissural infiltration, abscesses, acute haemorrhoidal attacks or inflammatory bowel disease
- Patients having idiopathic anal fissure in the anterior anal midline
- Patients having lateral or multiple fissures
- Patients having anal or perianal cancer
- Patients who underwent previous anal surgery or have cicatricial alterations or post-surgical cicatricial lesions
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 |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®) | Biological | – |
Primary outcome
Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
1 secondary outcome
Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
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 29 Apr 2020.
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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.
Ipsen Medical Director study director
Ipsen
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A in people with Anal Fissure, run by Ipsen at 7 sites in 4 countries.
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 3 inclusion and 11 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 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia, Poland, Romania, Tunisia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2020.