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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

NCT00477490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 799

Last updated 2015-11-02

Study results available
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Summary

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

Conditions

  • Nocturia

Interventions

DRUG

desmopressin acetate

Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg

DRUG

Placebo

Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT00477490 on ClinicalTrials.gov