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A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo in Water-loaded Male and Female Japanese Nocturia Patients (Single Dose), and to Study the Efficacy of 4 Different Dose Levels of Minirin Melt and Placebo After 28 Days of Dosing (Multiple Doses) (NOC)
This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient population. In particular, the trial is designed to link the duration of action to the clinical endpoint. Furthermore, the trial is designed to describe the safety of four different dose levels of desmopressin.
Details
| Lead sponsor | Ferring Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 116 |
| Start date | 2010-07 |
| Completion | 2011-04 |
Conditions
- Nocturia
Interventions
- Desmopressin
- Placebo
Primary outcomes
- Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1 — Day 1
Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production \<0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to \>0.12 mL/kg/min, but no longer than 12 hours. - Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2 — 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Countries
Japan