Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
216
Countries
1
Sites
5
Daytime urinary incontinence
The primary objective is to investigate if abrupt withdrawal versus phased withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 27 May 2024 → ongoing
- Decision date (initial)
- 2024-04-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The primary objective is to investigate if abrupt withdrawal versus phased withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence.
Secondary objectives 1
- The secondary objective is to evaluate whether abrupt and/or phased termination is associated with any type of withdrawal syndrome involving other symptoms than incontinence. Furthermore, the effect of treatment on well-being and quality of life.
Conditions and MedDRA coding
Daytime urinary incontinence
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10008523 | Childhood incontinence | 10038359 |
| 21.1 | LLT | 10021642 | Incontinence of urine | 10038359 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation any study specific procedures.
- Age 5 to 14 years (inclusive) at the time of signing the consent.
- Diagnose with urinary incontinence as per ICCS criteria.
- Pharmacological treatment with solifenacin and/or mirabegron.
- Continence has been achieved on pharmacological therapy with solifenacin and/or mirabegron.
- Previously withdrawal attempts are accepted.
- Continence remained on the same dosage of medication for a minimum of three months.
Exclusion criteria 1
- Neurogenic detrusor overactivity (neurogenic bladder)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP12507416 · ATC
- Active substance
- Solifenacin Succinate
- Substance synonyms
- (3R)-1-Azabicyclo[2.2.2]octan-3-yl (1S)-1-phenyl-3,4-dihydroisoquinoline-2(1H)-carboxylate hydrogen butanedioate, YM-905
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 70 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- G04BD08 — SOLIFENACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP156573 · ATC
- Active substance
- Mirabegron
- Substance synonyms
- YM178
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 350 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- G04BD12 — MIRABEGRON
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Hospitalsparken 15
- City
- Herning
- Postcode
- 7400
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Ann-Kristine Mandøe Svendsen
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Ann-Kristine Mandøe Svendsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 216 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Esbjerg Sygehus
Pediatric and Adolescent Medicine, Finsensgade 35, 6700, Esbjerg
Region Midtjylland
Pediatric and Adolescent Medicine, Hospitalsparken 15, 7400, Herning
Aarhus Universitetshospital
Pediatric and Adolescent Medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
Pediatric and Adolescent Medicine, Reberbansgade 15, 9000, Aalborg
Kolding Sygehus
Pediatric and Adolescent Medicine, Sygehusvej 24, 6000, Kolding
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-05-27 | 2024-05-27 | 2026-01-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-09 | Denmark | Acceptable 2024-04-19
|
2024-04-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-24 | Denmark | Acceptable | 2024-05-22 |