NCT00245479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
802

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

3.4 years

First QC Date

September 13, 2005

Last Update Submit

May 18, 2011

Conditions

Nocturnal Enuresis

Keywords

Primary nocturnal enuresis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 Arms (1)

1

OTHER
Drug: Primary nocturnal enuresis

Interventions

Primary nocturnal enuresisDRUG

Desmopressin

1

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation Hospital Saint Joseph, 185, rue Raymond Losserand

Paris, 75674, France

Location

Related Publications (3)

  • Van Herzeele C, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Predictive parameters of response to desmopressin in primary nocturnal enuresis. J Pediatr Urol. 2015 Aug;11(4):200.e1-8. doi: 10.1016/j.jpurol.2015.03.007. Epub 2015 May 21.

    PMID: 26059526DERIVED

  • Van Herzeele C, De Bruyne P, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Safety profile of desmopressin tablet for enuresis in a prospective study. Adv Ther. 2014 Dec;31(12):1306-16. doi: 10.1007/s12325-014-0173-1. Epub 2014 Dec 12.

    PMID: 25504157DERIVED

  • 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. doi: 10.1111/j.1742-1241.2008.01956.x.

    PMID: 19125991DERIVED

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 28, 2005

Study Start

April 1, 2002

Primary Completion

September 1, 2005

Study Completion

November 1, 2006

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations

FR(1)