Clinical trial • Phase IV • Other

DESMOPRESSIN for Nocturnal enuresis

Phase IV trial of DESMOPRESSIN for Nocturnal enuresis.

Overview

Trial Therapeutic Area
Other
Trial Disease
Nocturnal enuresis
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
14-03-2025
First CTIS Authorization Date
17-06-2025

Trial design

Comparison between Minirin (desmopressin oral lyophilisate) and Desmopressin "Sandoz" (sublingual desmopressin acetate). Doses/schedule not specified in the trial record; SmPC documents reference 60 µg, 120 µg and 240 µg formulations.-controlled Phase IV trial across 1 site in Denmark.

Comparator
Comparison between Minirin (desmopressin oral lyophilisate) and Desmopressin "Sandoz" (sublingual desmopressin acetate). Doses/schedule not specified in the trial record; SmPC documents reference 60 µg, 120 µg and 240 µg formulations.
Target Sample Size
24

Eligibility

Recruits 24 paediatric patients.

Pregnancy Exclusion
5. Pregnant or lactating girl.
Vulnerable Population
Participants are children aged 8-14 years (isVulnerablePopulationSelected: true). Parent/guardian informed consent is required; age-appropriate child information and assent materials are provided (documents include 'Brneinformation 8-11 ar' and 'Brneinformation 12-14 ar'), plus parent information ('Forldreinformation') and consent forms ('Samtykkeerklring', 'Fuldmagt').

Inclusion criteria

  • {"criterion_text":"- 1. Children aged 8-14 years.\n- 2. Diagnosis of NE.\n- 3. 3 or more wet nights per week.\n- 4. Completion of a 7-day home measurement of urine output and a 2-day fluid intake measurement prior to Visit 1."}

Exclusion criteria

  • {"criterion_text":"- 1. Recurrent urinary tract infections.\n- 2. Anamnestic, clinical or laboratory findings that can be related to dis-eases or conditions that might affect the parameters investigated.\n- 3. Neurological and/or known clinically significant anatomical abnormal-ities of the urinary tract.\n- 4. Former operations in the urinary tract.\n- 5. Pregnant or lactating girl.\n- 6. Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatraemia or SADH."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1)\tArea under the curve (AUC) (power based on this endpoint).","definition_or_measurement_approach":"Not specified beyond 'Area under the curve (AUC) (power based on this endpoint).' (pharmacokinetic AUC endpoint)."}

Secondary endpoints

  • {"endpoint_text":"- 1)\tPlasmaconcentration (Cmax)\n- 2)\tTime to maximum concentration (Tmax)\n- 3)\tUrine osmolality (Uosm)\n- 4) Urine output (uvol,ml)\n- 1)\tTaste\n- 2)\tTextur\n- 3)\t Preference","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
24
Recruitment Window Months
34
Consent Approach
Parental/guardian informed consent required; age-appropriate child information and assent materials provided (documents: 'Brneinformation 8-11 ar', 'Brneinformation 12-14 ar'), parent information ('Forldreinformation'), consent forms ('Samtykkeerklring', 'Fuldmagt'). No languages specified in the available record.

Methods

  • Social media postings (document: 'Opslag til sociale medier' - recruitment arrangements for publication).

Geography

Total Number Of Sites
1
Total Number Of Participants
24

Denmark

Earliest CTIS Part Ii Submission Date
24-05-2025
Latest Decision Or Authorization Date
05-01-2026
Processing Time Days
226
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Region Midtjylland
Department Name
Dept. of Paediatrics
Principal Investigator Name
Søren Rittig
Principal Investigator Email
rittig@clin.au.dk
Contact Person Name
Søren Rittig
Contact Person Email
rittig@clin.au.dk
Number Of Participants
24

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":"GCP enhederne","duties_or_roles":"sponsorDuties codes: 1, 8, 9; contact email gcp@clin.au.dk","organisation_type":"Health care"}

Investigational products

Investigational Product Name
Minirin, frysetørrede tabletter
Active Substance
DESMOPRESSIN
Modality
Peptide/protein/enzyme
Routes Of Administration
OROMUCOSAL
Route
Oromucosal
Authorisation Status
Authorised (marketingAuthNumber: 36522)
Dose Levels
60 µg, 120 µg, 240 µg
Maximum Dose
240 µg
Investigational Product Name
Desmopressin "Sandoz", sublinguale resoribletter
Active Substance
DESMOPRESSIN ACETATE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBLINGUAL USE
Route
Sublingual
Authorisation Status
Authorised (marketingAuthNumber: 67759)
Dose Levels
60 µg, 120 µg, 240 µg
Maximum Dose
240 µg

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