Nocturia
Conditions
Brief summary
Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year
Interventions
DRUGDesmopressin ODT 25 μg
DRUGDesmopressin ODT 50 μg
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
One dose level (25 μg desmopressin OCD) is included for female subjects and will be open-labelled for all female subjects. Two different dose levels (25 μg desmopressin and 50 μg desmopressin ODT are included for male subjects in a double-blinded manner. Male subjects continuing from trial 000130 will continue their randomised treatment and subjects who received placebo will be randomised to one of the 2 dose levels (25 μg desmopressin or 50 μg desmopressin ODT). New male subjects will be allocated to receive 50 μg desmopressin ODT in an open-labelled manner.
Intervention model description
The trial is designed as partly an extension trial for subjects completing trial 000129 (female subjects) and 000130 (male subjects) and partly as a trial for new female and male subjects.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(for subjects who participated in trials 000129 or 000130): * Written informed consent prior to performance of any trial-related activity for the 000131 trial * Has completed participation in trial 000129 or 000130
Exclusion criteria
(for subjects who participated in trials 000129 or 000130): * Hyponatraemia (serum sodium level \<135 mmol/L) at Visit 7 in trial 000129 or 000130 * Withdrawal from clinical trial 000129 or 000130 Inclusion Criteria (for subjects who did not participate in trials 000129 or 000130): * Written informed consent prior to performance of any trial-related activity * Adult ≥20 years of age * Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1a * Nocturnal polyuria at the end of screening period prior to Visit 1b * Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1a and Visit 1b * Has given agreement about contraception during the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The frequency and severity of adverse events | Up to 1 year | During long-term treatment |
| Clinically significant changes in laboratory values and vital signs | Up to 1 year | During long-term treatment |
| The incidence and severity of hyponatraemia | Up to 1 year | Measured by serum sodium levels during long-term treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean Nocturnal Polyuria Index (NPI) | Week 12, 24, 40 and 52 | — |
| Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) | Week 12, 24, 40 and 52 | — |
| Change from baseline in mean number of nocturnal voids | Week 12, 24, 40 and 52 | — |
| Change from baseline in bother score | Week 12, 24, 40 and 52 | Assessed by the Hsu 5-point Likert bother scale |
| Change from baseline in Insomnia Severity Index (ISI) | Week 12, 24, 40 and 52 | — |
| Change from baseline in mean time to first awakening to void | Week 12, 24, 40 and 52 | — |
| Change from baseline in mean nocturnal urin volume | Week 12, 24, 40 and 52 | — |
Countries
Japan
Outcome results
None listed