NCT00209261

Brief Summary

To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks. To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data. To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2004

Shorter than P25 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

December 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

8 months

First QC Date

September 13, 2005

Last Update Submit

May 18, 2011

Conditions

Primary Nocturnal Enuresis

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period.

    6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.

Secondary Outcomes (6)

  • Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.

    3 weeks

  • The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine.

    3 weeks

  • Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.

    3 weeks

  • Safety comparison between the 2 formulations.

    6 weeks

  • Comparison of compliance between the 2 formulations.

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: MINIRIN Oral Lyophilisate

2

ACTIVE COMPARATOR
Drug: Minirin tablet

Interventions

MINIRIN Oral LyophilisateDRUG
1
Minirin tabletDRUG
2

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)

Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades

Paris, France

Location

Related Publications (3)

  • Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2.

    PMID: 40728007DERIVED

  • Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.

    PMID: 32364251DERIVED

  • Juul KV, Van Herzeele C, De Bruyne P, Goble S, Walle JV, Norgaard JP. Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis. Eur J Pediatr. 2013 Sep;172(9):1235-42. doi: 10.1007/s00431-013-1992-9. Epub 2013 May 16.

    PMID: 23677249DERIVED

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

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
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2004

Primary Completion

August 1, 2005

Study Completion

September 1, 2005

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations

FR(1)