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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 19, 2009

Start Date ^ICMJE

April 2002

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00245479 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

• 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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Label, Multi-National Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

Brief 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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment

Condition ^ICMJE

Nocturnal Enuresis

Intervention ^ICMJE

Drug: Primary nocturnal enuresis

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

802

Completion Date

November 2006

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 15 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00245479

Responsible Party

Hjort, Director, Ferring Pharmaceuticals

Study ID Numbers ^ICMJE

FE992026 CS002

Study Sponsor ^ICMJE

Ferring Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

Information Provided By

Ferring Pharmaceuticals

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP