CompletedPhase 3

A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).

Japan20 participantsStarted 2011-01

Plain-language summary

This is an open-label dose-titration study in Japanese Central Diabetes Insipidus (CDI) patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of desmopressin.

Who can participate

Age range6 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Failure to increase urine osmolality above 300 mOsm/kg during a period of fluid deprivation sufficient to raise plasma osmolality and sodium above the upper limit of normal level for the reference laboratory (usually 295 mOsm/kg and 148 mEq/l, respectively)
✓. Complete and continuous control of the DI by desmopressin therapy without "breakthrough" diuresis, hypernatremia, hyponatremia, or symptoms or signs of water intoxication.
✓. A deficient plasma vasopressin response to osmotic or non-osmotic stimulation.
✓. Absence of the posterior pituitary bright spot on T-1 weighted midsagittal magnetic resonance imaging (MRI) of the brain.

What they're measuring

Change from Baseline in 24-hour Urine Volume

Timeframe: Day 0, Week 4

Trial details

NCT IDNCT01280188

SponsorFerring Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-08

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