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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-09-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Primary Nocturnal Enuresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

MINIRIN Oral Lyophilisate

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

Minirin tablet

Intervention Type DRUG

Interventions

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MINIRIN Oral Lyophilisate

Intervention Type DRUG

Minirin tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes