Nocturia associated with nocturnal polyuria MedDRA version: 16.1 Level: LLT Classification code 10064016 Term: Nocturnal polyuria System Organ Class: 100000004857
Conditions
Interventions
Product Code: ASP7035
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ASP7035
Other descriptive name: N-(2-Hydroxyethyl)-2-[(Z)-4,4,7-trifluoro-1-{4-[(R)-2-fluoropropoxy]-2- (trifluorome
Sponsors
Tacurion Pharma Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An institutional review board (IRB)/independent ethics committee (IEC)-approved written informed consent form including privacy language per national regulations must be obtained from the patient before any study related procedures (including withdrawal of prohibited medication, if applicable). 2. Patient is 60 to 85 years of age. 3. Patient has a mean = 2.5 nocturnal voids at the end of the 2-week placebo run-in. 4. Patient has a mean = 2.5 nocturnal voids for at least six months by history 5. 24-hour urine: urine output of 79 kg. 6. Serum sodium concentration is > 135 mmol/L. 7. Serum triglycerides are 1.0 defined as: nocturnal urine volume functional bladder capacity (largest single volume voided) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 128
Exclusion criteria
Exclusion criteria: 1. Incontinence resulting in nocturnal enuresis (occasional stress or urge incontinence during the daytime is not exclusionary) or severe stress incontinence 2. Diabetes insipidus (central or nephrogenic 3. Uncontrolled diabetes mellitus (any Type I or II) • Fasting blood glucose > 140 mg/dL • Admitted to a hospital for treatment of diabetes or diabetes-related illness in the past 12 weeks • Not under a physician care for diabetes mellitus • Has not been on stable doses of oral hypoglycemic drug(s) and/or long acting insulin for 4 weeks prior to screening and 3000 mL/24 hr for patients = 79 kg and > 3500 mL/24 hr for patients > 79 kg) or thirst disorders 6. Uncontrolled hypertension (systolic > 165 mmHg, diastolic > 100 mm Hg), unstable angina or other unstable clinical finding or condition that, in the opinion of the investigator, would be negatively affected by the study medication or that would potentially affect the study outcomes. 7. Urinary retention (post void residual of > 100 mL assessed by ultrasound or catherization); assessed during the screening period 8. Evidence of hepatic insufficiency or inflammation (i.e., > 2 x upper limit of normal [ULN] for total bilirubin, unless the patient has a history of Gilbert’s syndrome or = 2 x ULN for alanine transaminase [ALT] and aspartate aminotransferase [AST]) 9. Evidence of renal insufficiency (glomerular filtration rate [GFR] 4.0 must have had a negative prostate biopsy within the last 6 months 29. Treatment with any investigational drug within 30 days or within five elimination half lives prior to screening, whichever is greater 30. Taking loop diuretics within 6 months of screening or planned u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the change in the number of nocturnal voids from baseline to the highest dose before hyponatremia occurs or the last dosing period To determine the change in the duration of the first sleep period from baseline to the last highest dose before hyponatremia occurs or the last dosing period ;Secondary Objective: To determine the treatment responder rate, defined as the proportion of patients with at least 33% reduction from baseline in the number of nocturnal voids To determine the change in nocturnal urine volume from baseline to the highest dose before hyponatremia occurs or the last dosing period To determine the therapeutic ratio, defined as the ratio of the safe, highest effective dose not causing hyponatremia and the lowest dose meeting efficacy criteria To investigate the safety and tolerability of ASP7035 in patients with nocturia associated with nocturnal polyuria ;Primary end point(s): The change in mean number of nocturnal voids from baseline to the last hyponatremia free dose The change in average number of hours of first sleep duration (time to bed with intent to sleep to time of first waking for the purpose of voiding) from baseline to the last hyponatremia-free dose;Timepoint(s) of evaluation of this end point: The timepoint for evaluation is from baseline to last hyponatremia-free dose. This duration is anywhere from 2 weeks (baseline) to 12 weeks (6 dose levels/2 weeks per level) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Descriptive analyses of the proportion of patients who had at least 33% reduction from baseline overall and at each escalation dose The average urine volume and the change from baseline The therapeutic ratio (ratio of the safe, highest effective dose not causing hyponatremia and the lowest dose meeting efficacy criteria) will be calculated for each patient and summarized ;Timepoint(s) of evaluation of this end point: The timepoint for evaluation is from baseline to last hyponatremia-free dose. This duration is anywhere from 2 weeks (baseline) to 12 weeks (6 dose levels/2 weeks per level) | — |
Countries
Belgium, Poland, Romania
Contacts
Public ContactSenior Reg Affairs Specialist
PPD
Outcome results
None listed