A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00209261

Acronym

PALAT

Enrollment

221

Registered

2005-09-21

Start date

2004-12-31

Completion date

2005-09-30

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Nocturnal Enuresis

Brief summary

To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks. To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data. To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations

Detailed description

Interventions

DRUGMINIRIN Oral Lyophilisate

DRUGMinirin tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

Yes

Inclusion criteria

* Children suffering from primary nocturnal enuresis with no organic pathology. * Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France). * Children with a minimum of 6 wet nights in 2 weeks.

Exclusion criteria

* Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms. * Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine. * Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency. * Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period.	6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.

Secondary

Measure	Time frame
The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine.	3 weeks
Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.	3 weeks
Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.	3 weeks
Comparison of compliance between the 2 formulations.	6 weeks
The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment.	6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
Safety comparison between the 2 formulations.	6 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026