Overview
Sponsor-declared trial summary
Chronic anal fissure
To assess whether the technique of ultrasound-guided botulinum toxin infiltration is more effective and safer than the standard technique, by controlling the infiltration sites. The aim is to analyze whether the location of the botulinum toxin infiltration is an important factor in the result of the treatment. percenta…
Key facts
- Sponsor
- Hospital Universitario de Burgos
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-01-22
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520748-13-01
- EudraCT number
- 2021-002819-60
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To assess whether the technique of ultrasound-guided botulinum toxin infiltration is more effective and safer than the standard technique, by controlling the infiltration sites.
The aim is to analyze whether the location of the botulinum toxin infiltration is an important factor in the result of the treatment. percentage to assess whether the botulinum toxin infiltration is more effective and safer than the standard one.
On the other hand, the aim is to standardize a technique and make it much more precise for the localization of the infiltration, through the use of the endorectal ultrasound probe. Therefore, our objective is to establish a novel technique that complements the standard technique, is reproducible and does not increase the risks and is even safer, as it controls the site of toxin infiltration.
Conditions and MedDRA coding
Chronic anal fissure
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-520748-13-00 | Treatment of Chronic Anal Fissure with Ultrasound-Guided Inter-Sphincteric Injections of Botulinum Toxin A | Hospital Universitario de Burgos |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All patients of legal age who sign the informed consent form and are diagnosed with chronic anal fissure will be included in the study. Chronic anal fissure will be considered to be that which has been evolving for more than 6 weeks, despite various hygienic-dietary and/or relaxing treatments (NTG) or calcium blockers and which macroscopically presents any of the aspects of chronicity referred to: indurated edges, observation in the fundus of IAF fibers and/or sentinel polyp that persists for more than 6 weeks.
Exclusion criteria 1
- Patients in whom botulinum toxin injection is contraindicated are excluded from the study: patients with alterations of neuromuscular transmission such as myasthenia gravis, Lambert Eaton myasthenic syndrome, inflammatory bowel disease, concomitant treatment with aminoglycosides, pregnancy or lactation, asthma or adverse reactions to treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- VAS scale to quantify pain. Wesner scale to assess fecal incontinence It is a 20-point scale FIQL (Fecal Incontinence Quallity of Life) scale of quality of life, in cases of incontinence. Measurement of the thickness of the EAI by endorectal ultrasound
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Botulinum Toxin Type A 300 units Powder for solution for injection
PRD527195 · Product
- Active substance
- Botulinum Toxin Type a - Haemagglutinin Complex
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 30 U unit(s)
- Max total dose
- 30 U unit(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- PL 34926/0015
- MA holder
- IPSEN LTD
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario de Burgos
- Sponsor organisation
- Hospital Universitario de Burgos
- Address
- Avda Islas Baleares 3, Research Unit Research Unit
- City
- Burgos
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario de Burgos
- Contact name
- Jorge Labrador
Public contact point
- Organisation
- Hospital Universitario de Burgos
- Contact name
- Jorge Labrador
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo FACBOTOX v1 15042021 definitivo | 1 |
| Recruitment arrangements (for publication) | Protocolo FACBOTOX v1 15042021 definitivo | 1 |
| Subject information and informed consent form (for publication) | Consentimiento | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Botulinum toxin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-22 | Spain | Acceptable 2025-01-22
|
2025-01-22 |