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 Overview
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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

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

Official Title
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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)

Conditions
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Primary Nocturnal Enuresis

Intervention / Treatment
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* Drug: MINIRIN Oral Lyophilisate
* Drug: Minirin tablet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: MINIRIN Oral Lyophilisate<br> <br> |
| Active Comparator: 2<br> | Drug: Minirin tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations. |  | 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. |  | 3 weeks | 
| Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3. |  | 3 weeks | 
| Safety comparison between the 2 formulations. |  | 6 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. |