A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
Information source: Ferring Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nocturnal Enuresis
Intervention: Primary nocturnal enuresis (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 overall response to desmopressin treatment among previously untreated
enuretic children aged 5-15 years after 3 and 6 months of treatment.
To investigate the influence of possible predictive factors on response after 3 and 6 months
of treatment.
To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety
profile of oral desmopressin in children with primary nocturnal enuresis.
Clinical Details
Official title: An Open Label, Multi-National Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
Study design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment
Primary outcome: To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment
Secondary outcome: To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.
Detailed description:
To evaluate the overall response to desmopressin treatment among previously untreated
enuretic children aged 5-15 years after 3 and 6 months of treatment.
To investigate the influence of possible predictive factors on response after 3 and 6 months
of treatment.
To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety
profile of oral desmopressin in children with primary nocturnal enuresis.
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
Foundation Hospital Saint Joseph, 185, rue Raymond Losserand, Paris Cedex 14 75674, France
Additional Information
Starting date: October 2001
Ending date: October 2003
Last updated: February 27, 2007
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