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Trial · Interventional

CompletedPhase 4Registry data

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

Short name DRIP

NCTNCT00245479 (opens ClinicalTrials.gov in a new tab)Other idFE992026 CS002
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Desmopressin, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 4
Enrollment
802 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

France

Start
Apr 2002
Primary completion
Sept 2005
Completion
Nov 2006
First posted
28 Oct 2005 (estimated)
Last update posted
19 May 2011 (estimated)
Conditions
Nocturnal Enuresis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200220032004200520062007
  1. Ph 4

    DRIP

    NCT00245479

    Apr 2002 to Nov 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Primary nocturnal enuresisDrug

Arms1

  • Other

    1

Primary outcomes1

Outcomes the sponsor listed as primary.

  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)

  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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

2 results

Predictive parameters of response to desmopressin in primary nocturnal enuresis.

Van Herzeele et al. 2015Journal of pediatric urologycited by 30

PMID 26059526DOI 10.1016/j.jpurol.2015.03.007PUB-26059526

Full text at the publisher2 results
Publisher pageSee results (2)

More studies

2 studies on this page

Indexing hint: Clinical trial · 2014

Safety profile of desmopressin tablet for enuresis in a prospective study.

Van Herzeele et al. 2014Advances in therapycited by 13

PMID 25504157DOI 10.1007/s12325-014-0173-1PUB-25504157

Full text at the publisher
Publisher page

Indexing hint: Clinical trial · 2009

Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study.

Lottmann et al. 2009International journal of clinical practicecited by 24

PMID 19125991DOI 10.1111/j.1742-1241.2008.01956.xPUB-19125991

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 5 Years up to 15 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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