Clinical trial • Phase IV • Gastroenterology
BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX for Chronic anal fissure
Phase IV trial of BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX for Chronic anal fissure.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Chronic anal fissure
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 22-01-2025
- First CTIS Authorization Date
- 22-01-2025
Trial design
Randomised, standard technique: infiltration guided by external palpation (usual clinical practice) versus ultrasound-guided endorectal probe infiltration; both approaches use the same doses of botulinum toxin and the same time points (dose and exact schedule not specified).-controlled Phase IV trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Standard technique: infiltration guided by external palpation (usual clinical practice) versus ultrasound-guided endorectal probe infiltration; both approaches use the same doses of botulinum toxin and the same time points (dose and exact schedule not specified).
- Target Sample Size
- 50
Eligibility
Recruits 50 Participants must be of legal age and sign informed consent. No vulnerable population selected; assent or parent/guardian consent is not applicable..
- Pregnancy Exclusion
- pregnancy or lactation
- Vulnerable Population
- Participants must be of legal age and sign informed consent. No vulnerable population selected; assent or parent/guardian consent is not applicable.
Inclusion criteria
- {"criterion_text":"- 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
- {"criterion_text":"- 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 endpoints
- {"endpoint_text":"- VAS scale to quantify pain.","definition_or_measurement_approach":"Pain measured by Visual Analogue Scale (VAS)."}
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Fecal incontinence assessed using the Wesner scale; quality of life assessed using the 20-point FIQL (Fecal Incontinence Quality of Life) scale."}
- {"endpoint_text":"- Measurement of the thickness of the EAI by endorectal ultrasound","definition_or_measurement_approach":"Measurement of external anal internal (EAI) thickness using endorectal ultrasound imaging."}
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent required from participants of legal age who will sign the informed consent form. A subject information and informed consent form document is listed; languages and age-specific documents not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 50
Spain
- Earliest CTIS Part Ii Submission Date
- 22-01-2025
- Latest Decision Or Authorization Date
- 22-01-2025
- Processing Time Days
- 0
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Hospital Universitario de Burgos
- Department Name
- Surgery
- Contact Person Name
- Angel Martinez
- Contact Person Email
- msaiz@hubu.es
- Number Of Participants
- 50
Sponsor
Primary sponsor
- Full Name
- Hospital Universitario de Burgos
- Organisation Type
- Health care
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Botulinum Toxin Type A 300 units Powder for solution for injection
- Active Substance
- BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INFILTRATION
- Route
- INFILTRATION
- Authorisation Status
- Authorised (marketing authorisation PL 34926/0015, authorisationCountryCode: GB)
- Maximum Dose
- 30 U unit(s)
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