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Completed

NCT Number: NCT00245479

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

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.

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Key information

Conditions

Nocturnal Enuresis Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mental Disorders Urination Disorders Urogenital Diseases Urologic Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Foundation Hospital Saint Joseph, 185, rue Raymond Losserand

Paris, 75674, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary nocturnal enuresis

Drug

Desmopressin

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

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

  2. To evaluate the proportion of patients achieving dryness.

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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: DRIP

Important dates

Study start
2002
Primary completion
2005
Study completion
2006
First posted
Oct 28, 2005
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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