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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245479

Acronym

DRIP

Enrollment

802

Registered

2005-10-28

Start date

2002-04-30

Completion date

2006-11-30

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal Enuresis

Keywords

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

Interventions

DRUGPrimary nocturnal enuresis

Desmopressin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026