EUCTR2006-004854-26-DE进行中（未招募）不适用
A multicenter, randomized, double-blind, parallel group, phase II, forced dose titration study to investigate the efficacy and safety of 400mg and 600mg flupirtine (ELB245) given once daily for 12 weeks (8 + 4 weeks) versus placebo and versus 4mg tolterodine given once daily in patients with incontinent overactive bladder (OAB)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- elbion AG
- 入组人数
- 275
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
- •Inclusion criteria to enter 2-week placebo run-in phase:
- •1.Male or female outpatients = 18 years of age
- •2.Symptoms of OAB for a minimum of 3 consecutive months prior to study entry; severity of OAB (as defined by patient reported symptoms of frequency = 8 micturition per 24 hours, urgency = 3 episodes per 24 hours, and urinary urgency incontinence on average = 1 per day), for a minimum of one month prior to study entry
- •3.Willing to comply with requirements of the study protocol including the completion of diaries and questionnaires
- •4.Ability to use a toilet independently and without difficulty
- •5.No treatment with any medication against OAB during the 4 weeks prior to study entry
- •6.Written informed consent
- •Inclusion criteria at randomization
- •1.Symptoms of OAB based on patient diary entries during the placebo run in phase with
- •= 8 micturitions per 24 hours (based on a 3-day average)
- •= 3 episodes of urgency (strong desire to void) per 24 hours (based on a 3-day average)
- •= 1 episode of incontinence per 24 hours (based on a 3-day average)
- •2.No treatment with any medication against OAB during the placebo run in phase
- •3.Inclusion criteria 3 to 6 above have to be fulfilled
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for 2-week placebo run-in phase:
- •1.Breastfeeding women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of <1% per year like hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine devices restricted to hormone contraceptive coil or vasectomy of the partner). The pregnancy test on Visit 1 needs to be negative in women of childbearing potential
- •2.Any local pathology, (e.g. urinary tract infections [symptomatic active or recurrent i.e. four or more urinary tract infections per year], bladder stones and/or tumors, bladder, urethral or rectal fistulae, diagnosis of interstitial cystitis) that might cause the bladder symptoms
- •3.Significant stress urinary incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female patients confirmed by cough provocation test), as well as post-operative incontinence
- •4.Any neurological disease affecting bladder function or muscle strength (e.g. Multiple Sclerosis, Parkinson’s Disease, Stroke, Myasthenia Gravis)
- •5.Patient history of any lower urinary tract surgery (with the exception of periurethral injections performed at least 6 months ago) or previous pelvic irradiation at any time
- •6.Local administration of botulinum toxin within the last 9 months in the lower urinary tract
- •7.Start or change of a behavioral bladder training program or of performance of pelvic muscle exercises (biofeedback) in the 3 months prior to and during the study
- •8.Post voiding residual volumes larger than 250ml or symptoms of clinically relevant bladder outlet obstruction shown within 3 months prior to the clinical study
- •9.Nocturial polyuria (as defined as > one third of daily volume voided overnight)
- •10.History of liver disease and/or impaired liver function (alanine aminotransferase > 2 x upper limit of normal range (ULN), gamma glutamyl transferase > 2 x ULN, cholinesterase < 0.8 x lower limit of normal range) or significant hypoalbuminemia (< 32g/l)
- •11.Hepatic encephalopathy or history of hepatic encephalopathy
- •12.Cholestasis (alkaline phosphatase > 2 x ULN, bilirubin > 2 x ULN)
- •13.Chronic alcohol or drug abuse
- •14.Evidence of significantly impaired renal function (serum creatinine > 2 x ULN, blood urea nitrogen [BUN] > 2 x ULN)
- •15.Diabetes mellitus (type I or II) with significant peripheral neuropathy and/or polyuria
- •16.Inflammatory bowel disease such as Crohn’s disease, or ulcerative colitis
- •17.Uncontrolled narrow angle glaucoma
- •18.Any significant disease or condition other than OAB which may put the patient at risk because of participation in the study or which may influence the results of the study or the patient’s ability to participate in the study
- •19.Chronic use of carbamazepine or paracetamol (on more than 5 consecutive days or on more than 5 days per month)
- •20.Participation in any drug study in the preceding 3 months
- •21.Established hypersensitivity to flupirtine, tolterodine or the excipients of the study medication
- •22.Concomitant treatment with strong CYP3A4 inhibitors (such as macrolid antibiotics [e.g. erythromycin] or antifungal agents [e.g. ketoconazol, and itraconazole] and antiproteases), diuretics (except patients on a stable dose for longer than 6 months) and anticho
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