A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis - Clinical Trial for Nocturnal Enuresis | NCT00245479

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Primary nocturnal enuresis

About this trial

This is an interventional treatment trial for Nocturnal Enuresis focused on measuring Primary nocturnal enuresis

Eligibility Criteria

5 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Foundation Hospital Saint Joseph, 185, rue Raymond Losserand

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

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.

Full Information

NCT ID

NCT00245479

First Posted

September 13, 2005

Last Updated

May 18, 2011

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00245479

Brief Title

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

Acronym

DRIP

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 Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

April 2002 (undefined)

Primary Completion Date

September 2005 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nocturnal Enuresis

Keywords

Primary nocturnal enuresis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

802 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Primary nocturnal enuresis

Intervention Description

Desmopressin

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.

Title

To evaluate the proportion of patients achieving dryness.

Title

To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Development Support

Organizational Affiliation

Ferring Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Foundation Hospital Saint Joseph, 185, rue Raymond Losserand

City

Paris Cedex 14

ZIP/Postal Code

75674

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

26059526

Citation

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.

Results Reference

derived

PubMed Identifier

25504157

Citation

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.

Results Reference

derived

PubMed Identifier

19125991

Citation

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.

Results Reference

derived

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

Nocturnal Enuresis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial