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)

Phase 4CompletedNCT00209261

Ferring Pharmaceuticals221 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

221

Conditions

Primary Nocturnal Enuresis

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.

Secondary Outcomes

Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.

Time frame: 3 weeks

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.

Time frame: 3 weeks

Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.

Time frame: 3 weeks

Safety comparison between the 2 formulations.

Time frame: 6 weeks

Comparison of compliance between the 2 formulations.

Time frame: 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.

Time frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.

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)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes