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; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]; MedDRA version: 18.0Level: LLTClassification code 10064016Term: Nocturnal polyuriaSystem Organ Class: 100000004857

• Registration Number: EUCTR2013-003701-25-PL
• Lead Sponsor: Tacurion Pharma Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-14
• Last Update Posted: 1 February 2016

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 55 to 85 years of age.
3.Patient has a mean = 2.5 nocturnal voids for at least six months by history
4.Serum sodium concentration is = 135 mmol/L.
5.Serum triglycerides are < 400 mg/dL.
6. Female patients must be post-menopausal (two years 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
7.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 #6) 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.
8.Patient is willing and able to sign informed consent and comply with the study requirements.
Randomization Criteria
Patients must meet the following criteria at the end of the run-in period
using data from the run-in diary and other measures in order to be
randomized:
1.Compliance with diary on the last 7 days of the run-in period
2.Patient has a mean = 2.5 nocturnal voids during the 2 week run-in
period
3.24 hour urine: urine output of < 3000 mL/24 hr for patients weighing
= 79 kg and up to 3500 mL/24 hr for patients weighing > 79 kg (defined
as any instance in a 24 hour period)
4.Mean of = 33% of the patient's total urine volume produced at night
(all urine produced after going to bed with the intent to sleep up to and
including the first morning void) during the run-in period
5.Serum sodium concentration at the randomization visit, assessed at
the local laboratory, must be = 135 mmol/L
6.Absence of polydipsia (defined as 1 or more instances of fluid
consumption >3000 mL/24 hour for patients = 79kg and > 3500 mL/24
hour for patients > 79 k or thirst disorders as assessed by diary during
the run-in period
7.Nocturia index is > 1.0 defined as:
nocturnal urine volume / maximum single voided volume during a 24
hour period
8.Daytime urinary frequency of <12 voids/day during the run-in period
9.Reduction of <33% in frequency of nocturia and/or nocturnal urine
volume during the run-in phase. Change in nocturia frequency and
nocturnal urine volume is defined as a % change in the mean of the last
three days of the run-in period compared to the mean of the first three
days of the run-in period.
10.Study drug compliance at the end of run-in period:
•Patients missed =3 doses during the run-in period AND
•Patients took all of the last 4 consecutive doses in the run-in period
11.In Investigator's assessment, based on all run-in diary data, the
patient DOES NOT have incontinence resulting in nocturnal enuresis
(occasional stress or urge incontinence is not exclusionary) or severe
stress incontinence
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1

Exclusion Criteria

1.Incontinence resulting in nocturnal enuresis or severe stress incontinence
2.Diabetes insipidus
3.Uncontrolled diabetes mellitus
4.Congestive heart failure
5.Polydipsia or thirst disorders in medical history at screening
6.Uncontrolled hypertension , 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 assessed during the screening period
8.Evidence of hepatic insufficiency or inflammation
9.Evidence of renal insufficiency
10.History of syndrome of inappropriate antidiuretic hormone
11.Nephrotic syndrome
12.History of urinary bladder or prostate surgery or pelvic radiation
13.Daytime urinary frequency of = 12 voids/day by history at screening
14.Current use of systemic glucocorticosteroids (except topical steroids) or planned at any time 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 one nocturia, BPH or OAB clinical study within the last 9 months or participated in more than one of these trials at any time will be excluded.
18.Clinical evidence of urinary tract infection (UTI), microscopic or grosshematuria 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.Planned used of desmopressin at any time during the study or use of desmopressin within the last 9 months in the setting of a clinical trial or
in more than one clinical trial.
26. Previous use of desmopressin as prescribed by a physician not in the context of a clinical trial.
27. Receipt of blood products or donation of blood products within 30 days of screening or planned at any time during the study
28.Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV) by medical history.
For subjects who do not have a current sample (within 3 months of screening visit test) submission of sample to central lab is acceptable.
29.Patient with a prostate-specific antigen (PSA) of > 8.0 must have had a negative prostate biopsy within the last 6 months. For patients with a
PSA between 4 and 8 the need for a negative prostate biopsy will be discussed on a case by case basis between the Investigator and the
Sponsor. For inclusion of these patients without biopsy, both the Investigator and the Sponsor need to agree that based on other information available (e.g. time course of PSA elevations in the past) the
likelihood of prostate cancer is low and that a biopsy would not be part of standard of care outside of the setting of this clinical trial. For patients
who did not have PSA assessed in the past, for whom it is not possible toverify this criterion, PSA may be assessed locally during the screening
period.
30.Treatment with any investigational drug withi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified