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)
Information source: Ferring Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Nocturnal Enuresis
Intervention: MINIRIN Oral Lyophilisate (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s):
Henri Lottmann, MD, Principal Investigator, Affiliation: Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades
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
Clinical Details
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 design: Randomized, Open Label, Active Control, Crossover Assignment
Primary outcome: 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.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: 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.
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
Eligibility
Minimum age: 5 Years.
Maximum age: 15 Years.
Gender(s): Both.
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
Locations and Contacts
Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades, Paris, France
Additional Information
Starting date: March 2004
Ending date: September 2005
Last updated: February 27, 2007
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