Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Nocturnal enuresis
Overall objective: to examine the pharmacokinetic and pharmacodynamic differences between the two desmopressin formulations (Minirin and Sandoz). 1) To examine the pharmacokinetic profiles 2) To examine the difference in the ability to concentrate the urine
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Decision date (initial)
- 2025-06-17
- 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: Pharmacokinetic
Overall objective: to examine the pharmacokinetic and pharmacodynamic differences between the two desmopressin formulations (Minirin and Sandoz).
1) To examine the
pharmacokinetic profiles
2) To examine the difference in the ability to concentrate the urine
Secondary objectives 1
- To fully examine the pharmacokinetic and pharmacodynamic profiles, secondary endpoint will also be evaluated: To evaluate the children’s experiences with the two drug formulations.
Conditions and MedDRA coding
Nocturnal enuresis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Children aged 8-14 years. 2. Diagnosis of NE. 3. 3 or more wet nights per week. 4. Completion of a 7-day home measurement of urine output and a 2-day fluid intake measurement prior to Visit 1.
Exclusion criteria 1
- 1. Recurrent urinary tract infections. 2. Anamnestic, clinical or laboratory findings that can be related to dis-eases or conditions that might affect the parameters investigated. 3. Neurological and/or known clinically significant anatomical abnormal-ities of the urinary tract. 4. Former operations in the urinary tract. 5. Pregnant or lactating girl. 6. Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatraemia or SADH.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1) Area under the curve (AUC) (power based on this endpoint).
Secondary endpoints 1
- 1) Plasmaconcentration (Cmax) 2) Time to maximum concentration (Tmax) 3) Urine osmolality (Uosm) 4) Urine output (uvol,ml 1) Taste 2) Textur 3) Preference
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Minirin, frysetørrede tabletter
PRD12040101 · Product
- Active substance
- Desmopressin
- Pharmaceutical form
- ORAL LYOPHILISATE
- Route of administration
- OROMUCOSAL
- Max daily dose
- 240 µg microgram(s)
- Max total dose
- 240 µg microgram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BA02 — DESMOPRESSIN
- Marketing authorisation
- 36522
- MA holder
- FERRING LÆGEMIDLER A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Desmopressin "Sandoz", sublinguale resoribletter
PRD12038612 · Product
- Active substance
- Desmopressin Acetate
- Pharmaceutical form
- SUBLINGUAL TABLET
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 240 µg microgram(s)
- Max total dose
- 240 µg microgram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BA02 — DESMOPRESSIN
- Marketing authorisation
- 67759
- MA holder
- SANDOZ A/S
- MA country
- Denmark
- 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
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Søren Rittig
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Mette Lunddorf
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP enhederne ORL-000013881
|
Aarhus N, Denmark | On site monitoring, Code 8, Code 9 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 24 | 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 23 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Changes - Protocol A pharmacokinetic study of Desmopressin - Minirin vs Sandoz | 4 |
| Protocol (for publication) | changes Protocol A pharmacokinetic study of Desmopressin Minirin vs Sandoz | 3 |
| Protocol (for publication) | Hjemmemaling | 1 |
| Protocol (for publication) | Protocol A pharmacokinetic study of Desmopressin - Minirin vs Sandoz | 4 |
| Protocol (for publication) | Sprgeskema | 1 |
| Recruitment arrangements (for publication) | changes informedconsent_patientrecruitmentprocedure | 2 |
| Recruitment arrangements (for publication) | changes-Opslag til sociale medier | 2 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure | 2 |
| Recruitment arrangements (for publication) | Opslag til sociale medier | 2 |
| Subject information and informed consent form (for publication) | Brneinformation 12-14 ar | 2 |
| Subject information and informed consent form (for publication) | Brneinformation 8-11 ar | 2 |
| Subject information and informed consent form (for publication) | changes Brneinformation 12-14 ar | 2 |
| Subject information and informed consent form (for publication) | changes Forldreinformation | 2 |
| Subject information and informed consent form (for publication) | changes Fuldmagt | 2 |
| Subject information and informed consent form (for publication) | changes-Brneinformation 8-11 ar | 2 |
| Subject information and informed consent form (for publication) | changes-Samtykkeerklring | 2 |
| Subject information and informed consent form (for publication) | Forldreinformation | 2 |
| Subject information and informed consent form (for publication) | Fuldmagt | 2 |
| Subject information and informed consent form (for publication) | Hjemmemaling | 1 |
| Subject information and informed consent form (for publication) | Samtykkeeklring | 2 |
| Subject information and informed consent form (for publication) | Sprgeskema | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC Desmopressin Sandoz sublinguale resoribletter 60 mikrog 120 mikrog og 240 mikrog | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC Minirin frysetrrede tabletter 60 mikrog 120 mikrog og 240 mikrog | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-14 | Denmark | Acceptable 2025-06-17
|
2025-06-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-05 | Denmark | Acceptable 2025-06-17
|
2026-01-05 |