Clinical trial • Not applicable • Other
SOLIFENACIN SUCCINATE for Daytime urinary incontinence | Childhood urinary incontinence
Not applicable trial of SOLIFENACIN SUCCINATE for Daytime urinary incontinence | Childhood urinary incontinence.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Daytime urinary incontinence | Childhood urinary incontinence
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 09-01-2024
- First CTIS Authorization Date
- 22-04-2024
Trial design
Abrupt withdrawal versus phased withdrawal of pharmacotherapy (solifenacin and/or mirabegron).-controlled Not applicable trial across 5 sites in Denmark.
- Comparator
- Abrupt withdrawal versus phased withdrawal of pharmacotherapy (solifenacin and/or mirabegron).
- Target Sample Size
- 216
- Trial Duration For Participant
- 365
Eligibility
Recruits 216 paediatric patients.
- Vulnerable Population
- Participants are children aged 5–14 years (minors); the custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study-specific procedures. The trial selects a vulnerable population (isVulnerablePopulationSelected = true). No separate assent process for older children or languages for consent are specified in the available documents.
Inclusion criteria
- {"criterion_text":"- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation any study specific procedures."}
- {"criterion_text":"- Age 5 to 14 years (inclusive) at the time of signing the consent."}
- {"criterion_text":"- Diagnose with urinary incontinence as per ICCS criteria."}
- {"criterion_text":"- Pharmacological treatment with solifenacin and/or mirabegron."}
- {"criterion_text":"- Continence has been achieved on pharmacological therapy with solifenacin and/or mirabegron."}
- {"criterion_text":"- Previously withdrawal attempts are accepted."}
- {"criterion_text":"- Continence remained on the same dosage of medication for a minimum of three months."}
Exclusion criteria
- {"criterion_text":"- Neurogenic detrusor overactivity (neurogenic bladder)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary outcome measure is recurrence of incontinence after withdrawal and up to 12 months follow-up, assessed by 14-day calendar of incontinence episodes.","definition_or_measurement_approach":"Recurrence of incontinence after withdrawal up to 12 months follow-up, assessed using a 14-day calendar recording incontinence episodes."}
Secondary endpoints
- {"endpoint_text":"- Secondary outcome measures are development of any withdrawal symptoms, assessed by questionnaire on withdrawal symptoms (Appendix 2), change from baseline up to 44 days after initiation of withdrawal.","definition_or_measurement_approach":"Assessment of any withdrawal symptoms by a withdrawal-symptoms questionnaire (Appendix 2); change from baseline measured up to 44 days after initiation of withdrawal."}
Recruitment
- Planned Sample Size
- 216
- Recruitment Window Months
- 45
- Consent Approach
- Custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study-specific procedures. Participants are aged 5–14 (minors). No details on assent procedures for children or language versions of consent documents are provided in the available records.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 216
Denmark
- Earliest CTIS Part Ii Submission Date
- 13-04-2024
- Latest Decision Or Authorization Date
- 22-05-2024
- Processing Time Days
- 39
- Number Of Sites
- 5
- Number Of Participants
- 216
Sites
- Site Name
- Kolding Sygehus
- Department Name
- Pediatric and Adolescent Medicine
- Contact Person Name
- Louise Winding
- Contact Person Email
- louise.winding1@rsyd.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Pediatric and Adolescent Medicine
- Contact Person Name
- Søren Hagstrøm
- Contact Person Email
- soha@rn.dk
- Site Name
- Esbjerg Sygehus
- Department Name
- Pediatric and Adolescent Medicine
- Contact Person Name
- Linda Kuhne-Qvist
- Contact Person Email
- Linda.Kuhne-qvist2@rsyd.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Pediatric and Adolescent Medicine
- Contact Person Name
- Konstantinos Kamperis
- Contact Person Email
- konskamp@rm.dk
- Site Name
- Region Midtjylland (Hospitalsparken 15, Herning)
- Department Name
- Pediatric and Adolescent Medicine
- Contact Person Name
- Luise Borch
- Contact Person Email
- luise.borch@rm.dk
Sponsor
Primary sponsor
- Full Name
- Region Midtjylland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"1","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- SOLIFENACIN
- Active Substance
- SOLIFENACIN SUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- No marketing authorisation specified (marketingAuthNumber = "-")
- Maximum Dose
- 10 mg daily (maxTotalAmount 70 mg)
- Investigational Product Name
- MIRABEGRON
- Active Substance
- MIRABEGRON
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- No marketing authorisation specified (marketingAuthNumber = "-")
- Maximum Dose
- 50 mg daily (maxTotalAmount 350 mg)
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