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A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

NCT00209261 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2011-05-19

No results posted yet for this study

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

Conditions

  • Primary Nocturnal Enuresis

Interventions

DRUG

MINIRIN Oral Lyophilisate

DRUG

Minirin tablet

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2005-08-31
Completion
2005-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00209261 on ClinicalTrials.gov