- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00209261
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)
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)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Paris, France
- Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
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Active Comparator: 1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
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6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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3 weeks
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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
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3 weeks
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Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.
Time Frame: 3 weeks
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3 weeks
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Safety comparison between the 2 formulations.
Time Frame: 6 weeks
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6 weeks
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Comparison of compliance between the 2 formulations.
Time Frame: 6 weeks
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6 weeks
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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.
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6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Nocturnal Enuresis
- Physiological Effects of Drugs
- Natriuretic Agents
- Hemostatics
- Coagulants
- Antidiuretic Agents
- Deamino Arginine Vasopressin
Other Study ID Numbers
- FE992026 CS022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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