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

Sponsor:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00245479

Purpose

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.

Condition	Intervention	Phase
Nocturnal Enuresis	Drug: Primary nocturnal enuresis	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Multi-national Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

Resource links provided by NLM:

MedlinePlus related topics: Bedwetting

Drug Information available for: Desmopressin Desmopressin acetate

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

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 Measures:

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.

Enrollment:	802
Study Start Date:	April 2002
Study Completion Date:	November 2006
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Primary nocturnal enuresis Desmopressin

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

Ages Eligible for Study:	5 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245479

Locations

France
Foundation Hospital Saint Joseph, 185, rue Raymond Losserand
Paris Cedex 14, France, 75674

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lottmann H, Baydala L, Eggert P, Klein BM, Evans J, Norgaard JP. Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study. Int J Clin Pract. 2009 Jan;63(1):35-45.

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00245479 History of Changes
Other Study ID Numbers:	FE992026 CS002
Study First Received:	September 13, 2005
Last Updated:	May 18, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ferring Pharmaceuticals:

Primary nocturnal enuresis

Additional relevant MeSH terms:

Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Deamino Arginine Vasopressin

Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012