DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nocturnal Enuresis

Intervention: Primary nocturnal enuresis (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

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: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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: April 2002
Last updated: May 18, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017