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 4

Completed

• Conditions: Primary Nocturnal Enuresis
• Interventions: Drug: MINIRIN Oral Lyophilisate; Drug: Minirin tablet

• Registration Number: NCT00209261
• Lead Sponsor: Ferring Pharmaceuticals

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

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 Timeline

• Study Start: 2004-12
• Primary Completion: 2005-08
• Study Completion: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	MINIRIN Oral Lyophilisate	-
2	Minirin tablet	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades; 🇫🇷 Paris, France