EUCTR2009-013088-20-PL进行中（未招募）不适用
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® as Applicable in Patients with Idiopathic Overactive Bladder with Urinary Incontinence
Allergan Ltd0 个研究点目标入组 534 人开始时间: 2009年10月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 534
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. Written informed consent has been obtained.
- •2. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained.
- •3. Written Data Protection Consent (EU sites only) has been obtained.
- •4. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
- •5. Patient is male or female, aged = 18 years old.
- •6. Patient weighs = 40 kg (88 lbs).
- •7. Patient has symptoms of idiopathic OAB (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening, determined by documented patient history.
- •8. Patient experiences = 3 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day, in the 3-day patient bladder diary completed during the screening period (see Section 8.3.2.5 Patient Bladder Diary).
- •9. Patient experiences urinary frequency, defined as an average of = 8 micturitions (toilet voids) per day i.e. a total = 24 micturitions in the 3-day patient bladder diary completed during the screening period (see Section 8.3.2.5 Patient Bladder Diary).
- •10. Patient has not been adequately managed with one or more anticholinergic agents for treatment of their overactive bladder symptoms, in the opinion of the investigator. Not adequately managed is defined as: • an inadequate response after at least a 4-week period of anticholinergic therapy on an optimized dose(s), i.e., patient was still incontinent despite anticholinergic therapy, or • limiting side effects after at least a 2-week period of anticholinergic therapy on an optimized dose(s). An optimized dose is defined as an approved dose for the indication of OAB.
- •11. Patient is willing to use clean intermittent catheterization (CIC) to empty the bladder at any time after study treatment if it is determined to be necessary by the investigator.
- •12. Patient has a negative pregnancy test result if female and of childbearing potential.
- •13. Patient has a negative urine dipstick reagent strip test at Randomization/Day 1 (for nitrites and leukocyte esterase) and, in the investigator’s opinion, patient is asymptomatic for UTI on day of treatment.
- •14. Patient is able to complete study requirements including using the toilet without assistance, is able to collect volume voided per micturition measurements over a 24-hour period, complete bladder diaries and questionnaires, and attend all study visits in the opinion of the investigator.
- •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 267
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 267
排除标准
- •The following are the key exclusion criteria (not exact wording) to ensure patients are not enrolled who are not in the target population:
- •No. 1: Patient has symptoms of OAB due to a known neurological reason (eg. spinal cord injury or multiple sclerosis)
- •No. 2: Patient has predominance of stress incontinence
- •No. 3: Patient has received anticholinergics or any other medications/therapies to treat symptoms of OAB including nocturia, within 7 days of the start of the screening period procedures.
- •No. 4: Patient uses CIC or indwelling catheter to mange their urinary incontinence No. 5: Patient has been treated with any intravesical pharmacologic agent within 12 months of randomisation
- •No. 6: Patient has had previous or current botulinum toxin therapy of any serotype for any urological condition.
- •No. 7: Patient has had previous or current botulinum toxin therapy of any serotype for any nonurological condition within 12 weeks of Randomization.
- •No. 8: Patient has been immunized for any botulinum toxin serotype.
- •No. 9: Patient has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than ‘overactive bladder’, that may affect bladder function. (Note: list given in protocol)
- •No. 10: Patient has a history of interstitial cystitis/painful bladder syndrome.
- •No. 11: Patient has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening.
- •No. 12: Patient has a history or current diagnosis of bladder cancer or other urothelial malignancy, and/or has uninvestigated suspicious urine cytology results. No. 13: Patient is male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of > 10 ng/mL at screening. Patients with a PSA level of =4 ng/mL but = 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator according to local site practice.
- •No. 14: Patient has evidence of urethral and/or bladder outlet obstruction at screening or Randomization.
- •No. 17: Patient has a 24hour total volume of urine voided > 3000 mL, collected over 24 consecutive hours during the 3-day bladder diary collection period prior to Randomization. Excluding patients based on potential risks associated with study drug or administration procedure: No. 15. Patient has a PVR urine volume of > 100 mL at screening.
- •No. 16. Patient has had urinary retention or an elevated PVR urine volume that has been treated with an intervention (such as catheterization) within 6 months of screening.
- •No. 18: Patient has a history of 2 or more urinary tract infections within 6 months of Randomisation/Day 1or is taking prophylactic antibiotics to prevent chronic UTIs.
- •No. 19: Patient has a serum creatinine level > 2 times the upper limit of normal at screening.
- •No. 20: Patient has current or previous uninvestigated hematuria. Patient with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction of the investigator.
- •No. 21: Patient has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis.
- •No. 22: Patient cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to Randomization.
- •No. 23: Patient has a known allergy or sensitivity to any botulinum toxin preparation (including the study medication preparation), anesthetics or antibiotics to be used during the study.
- •No. 24: Pati
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