Trial intelligence / Profile preview

Desmopressin Oral Melt vs Intranasal in Japanese CDI Patients

NCT01280188Phase 3

Key facts

Status: Completed
Start: Jan 2011
Primary completion: Aug 2011
Countries: 1
Sponsor: Ferring Pharmaceuticals
Modality: Peptides, Small Molecules

Drugs: desmopressin
Conditions: central diabetes insipidus (CDI)

Overview

Phase 3, open-label, single-arm trial of desmopressin in central diabetes insipidus (CDI), sponsored by Ferring Pharmaceuticals. Primary endpoint: Change from Baseline in 24-hour Urine Volume at Week 4. Started Jan 2011; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Desmopressin
Intranasal run-in followed by switch to Oral Melt.

Endpoints

Primary

Change from Baseline in 24-hour Urine VolumeWeek 4

Secondary

24-hour urine volumeWeek 4
Hourly diuresis rateWeek 4
Urine osmolalityWeek 4
Urine specific gravityWeek 4
Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravityWeek 4
Serum sodium levelMonth 13
Participants with Adverse Events Summarized by Incidence and SeverityMonth 13

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