Status:
COMPLETED
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)
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Primary Nocturnal Enuresis
Eligibility:
All Genders
5-15 years
Phase:
PHASE4
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-we...
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-we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00209261
Start Date
December 1 2004
End Date
September 1 2005
Last Update
May 19 2011
Active Locations (1)
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1
Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades
Paris, France