EUCTR2013-003701-25-BE进行中（未招募）不适用
A Phase II, Multicenter,Randomization, Double-Blind, Parallel Group, Placebo-Controlled, Forced Titration Proof of Concept Study to Assess Efficacy, Safety, Tolerability and the Therapeutic Ratio of ASP7035 in Patients with Nocturia Associated with Norturnal Polyuria
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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