A proof of concept study using ASP7035 tablets and placebo to assess the efficacy, safety and tolerability in patients with increased urination frequency and urine volume at night

Conditions: octuria associated with nocturnal polyuria
MedDRA version: 16.1Level: LLTClassification code 10064016Term: Nocturnal polyuriaSystem Organ Class: 100000004857
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2013-003701-25-BE

Lead Sponsor: Tacurion Pharma Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 128

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 < 3000mL/24 hr for patients weighing =79 kg and up to 3500 mL/24 hr for patients weighing > 79 kg.
6.Serum sodium concentration is > 135 mmol/L.
7.Serum triglycerides are < 400 mg/dL.
8.Female patients must be post-menopausal (one year or greater without menses), surgically incapable of childbearing (surgical removal of uterus and/or ovaries), or agreeable to practicing abstinence or two effective methods of birth control during the study period. Acceptable methods may include:
•Intrauterine device
•Spermicide
•Barrier contraception
•Hormonal contraception
9.If male, with female partners of child-bearing potential, the patient agrees to sexual abstinence or to use two highly effective methods of birth control (see criterion #8) during the study period and for 90 days after the last dose. Patient must not donate sperm during the study period and for 90 days after the last dose.
10.Patient is willing and able to sign informed consent and comply with the study requirements.
11.At least 33% of the patient’s total urine volume should be produced at night (patients who work during the night will not be eligible for the study).
12.Nocturia index is > 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

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 < 8 weeks for oral thiazolidinedione (glitazones)
4.Congestive heart failure (New York Heart Association [NYHA] Class II, III, or IV
5.Polydipsia (> 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] < 50 mL/min/1.73m2) by Modification of Diet in Renal Disease (MDRD) calculation method
10.History of syndrome of inappropriate antidiuretic hormone (SIADH)
11.Nephrotic syndrome
12.History of urinary bladder or prostate surgery or pelvic radiation
13.Daytime urinary frequency of = 12 voids/day; assessed during the placebo run-in phase
14.Use of steroids (except topical steroids) during the study
15.Females with pelvic prolapse greater than Stage II
16.Current or past malignancy (except cured basal or squamous carcinoma)
17.Patient has previously participated in a study with ASP7035, or trials for nocturia, BPH and OAB
18.Clinical evidence of urinary tract infection (UTI), microscopic or gross hematuria that has not been evaluated, bladder stone, bladder pain syndrome (BPS) or interstitial cystitis
19.Urinary bladder dysfunction of neurologic etiology that in the judgment of the investigator would interfere with study assessments
20.Multiple sclerosis, Parkinson’s disease or neurogenic detrusor over activity
21.Obstructive sleep apnea
22.Hyperkinetic limb disorders (e.g., restless leg syndrome) or other syndromes that disrupt sleep
23.Work or lifestyle that interferes with night time sleep (e.g., late night shift work)
24.Known alcohol or substance abuse within the last 24 months
25.Previous use of desmopressin
26.Receipt of blood products or donation of blood products within 30 days of screening
27.Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV) by medical history
28.Patient with a prostate-specific antigen (PSA) of > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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