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) (PALAT)

Ferring

Status and phase: Completed; Phase 4

Conditions: Primary Nocturnal Enuresis

Treatments: Drug: Minirin tablet; Drug: MINIRIN Oral Lyophilisate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00209261

FE992026 CS022

Details and patient eligibility

About

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

Full description

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

Enrollment: 221 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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221 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: MINIRIN Oral Lyophilisate

2

Active Comparator group

Treatment:

Drug: Minirin tablet