Nocturia
Conditions
Interventions
Product Name: Desmopressin orally disintegrating tablet
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: DESMOPRESSIN
CAS Number: 16679-58-6
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent has been given prior to performance of any trial-related activity 2. Male or female patients, aged 25-65 years at the time of written consent, who currently have a regular sleep/wake schedule with minimal daytime napping 3. Nocturia symptoms which have been present for =6 months prior to trial entry (patient-reported) 4. At least 2 nocturnal voids per night as judged by the Investigator during both 3-day diary periods 5. A nocturia index >1 (nocturnal urine production exceeding maximum voided volume) 6. A time-in-bed period of between 6.0 and 9.5 hours per night (based on screening diary and actigraphy) 7. The patient is able to read and understand the informed consent form and understand the trial procedures 8. Pre- or peri-menopausal women must have a negative pregnancy test and be willing and able to use a reliable method of contraception throughout the trial. In the context of this trial, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: implants, injectables, combined or progesterone only oral contraceptives, sexual abstinence or vasectomised (male patients or partners). Amenorrhea of more than 12 months duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test 9. Be willing and able to stay at the sleep centre as required by the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Evidence of severe voiding dysfunction defined as >10 nocturnal voids as documented on any given night in the voiding diary during the screening period 2. History of, or evidence of obstructive sleep apnoea (AHI >10) and PLMS (=10 arousals) as measured by PSG at Visit 1b 3. Evidence of other sleep disorders which are independent of nocturia 4. Signs or symptoms of any of the following diseases: • severe bladder outlet obstruction with a Q max 40 mL/kg/24 hours) 10. Syndrome of inappropriate antidiuretic hormone (SIADH) 11. Cardiac failure, evidence based on physical examination, cardiac medical history, and electrocardiogram (ECG) output 12. Uncontrolled hypertension 13. Uncontrolled diabetes mellitus 14. Hyponatraemia with a serum sodium level <135 mmol/L or history of hyponatraemia 15. Renal insufficiency: Serum creatinine must be within normal laboratory reference intervals and estimated glomerular filtration rate must be =50 mL/min 16. Known or suspected clinically significant hepatic and/or biliary diseases: •aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range (=2 X ULN) and total bilirubin level must not be more than 1.5 mg/dL •if AST and/or ALT =2 but =3 X ULN, total bilirubin level must be normal •if total bilirubin level 1.5-2.0 mg/dL, AST and/or ALT must be normal 17. Women who are pregnant, breastfeeding, or who plan to become pregna
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy Objectives • To investigate the relationship between nocturia, sleep, and daytime performance • To investigate the efficacy of desmopressin orally disintegrating tablets (50 µg in men and 25 µg in women) versus placebo for treatment of patients with nocturia with respect to nocturia, sleep, and daytime performance. Safety Objective • To confirm the safety of desmopressin orally disintegrating tablets (50 µg in men and 25 µg in women) in the treatment of nocturia. ;Secondary Objective: Not applicable; Primary end point(s): Efficacy Endpoints Nocturia Endpoints: • Mean number of nocturnal voids at Month 1 and Month 3 • Mean time to first void at Month 1 and Month 3. Sleep Endpoints: • Objective Measures of Sleep – polysomnography (PSG) • Objective Measures of Sleep - Actigraphy • Subjective Measures of Voiding and Sleep Daytime Endpoints: • Subjective Measures of Daytime Performance Safety Endpoints: • Incidence, type and severity of adverse events (AEs) • Clinically significant changes in laboratory values, vital signs, and physical examinations. ;Timepoint(s) of evaluation of this end point: Continually throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United Kingdom
Contacts
Public ContactClinical Development Support
Ferring Pharmaceuticals A/S
Outcome results
None listed