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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)

Primary Purpose

Primary Nocturnal Enuresis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
MINIRIN Oral Lyophilisate
Minirin tablet
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Nocturnal Enuresis

Eligibility Criteria

5 Years - 15 Years (Child)All SexesAccepts 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

Sites / Locations

  • Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.
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.
Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.
Safety comparison between the 2 formulations.
Comparison of compliance between the 2 formulations.
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.

Full Information

First Posted
September 13, 2005
Last Updated
May 18, 2011
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00209261
Brief Title
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)
Acronym
PALAT
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Nocturnal Enuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MINIRIN Oral Lyophilisate
Intervention Type
Drug
Intervention Name(s)
Minirin tablet
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.
Time Frame
3 weeks
Title
Safety comparison between the 2 formulations.
Time Frame
6 weeks
Title
Comparison of compliance between the 2 formulations.
Time Frame
6 weeks
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades
City
Paris
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32364251
Citation
Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
Results Reference
derived
PubMed Identifier
23677249
Citation
Juul KV, Van Herzeele C, De Bruyne P, Goble S, Walle JV, Norgaard JP. Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis. Eur J Pediatr. 2013 Sep;172(9):1235-42. doi: 10.1007/s00431-013-1992-9. Epub 2013 May 16.
Results Reference
derived

Learn more about this trial

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)

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