EUCTR2005-005868-93-GB进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects with Idiopathic Detrusor Overactivity
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
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
- Female
入选标准
- •1. Female, 18 to 65 years of age, inclusive.
- •2. A current primary diagnosis of OAB consistent with idiopathic detrusor overactivity with symptoms present for at least 6 months prior to Screening.
- •3. Idiopathic detrusor overactivity, demonstrated by a urodynamic observation, which is characterized by involuntary detrusor contraction during the filling phase and is associated with a sensation of urgency. Note: If a urodynamic assessment has been performed within 3 months of baseline (Visit 2), that assessment may serve as the screening measure provided the key urodynamic parameters (including maximum bladder capacity) are available for subsequent comparisons. The previous urodynamic assessment must have been performed by the same person who will perform the assessments for this trial and the subject must not have received treatment for OAB since the assessment was completed.
- •4. Evidence of frequency (=8 micturitions/24 hours) in combination with urinary during the 7 days prior to baseline (Visit 2) based on the micturition diary. ensure an accurate quantification of frequency, subjects must have recorded diaries for at least 4 out of the 7 days preceding baseline.
- •5. Willingness to participate in this study as evidenced by a signed, written consent form (ICF).
- •6. If of child-bearing potential (i.e., not post-menopausal or documented to sterile) willingness to avoid pregnancy and practice adequate birth control contraception, intrauterine devices, implantable devices, depot contraceptives, barrier method) from the time of study enrollment through at least 30 days dose of study medication.
- •7. Negative serum pregnancy test at Visit 1 (Screening) and negative urine Visit 2 (Randomization).
- •8. Agrees to refrain from blood donation during the course of the study.
- •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
- •1. Subjects who are pregnant or lactating.
- •2. Clinically significant abnormality or clinically significant unstable medical condition as indicated by medical history, physical examination, ECG results, clinical laboratory testing, or the investigator’s judgment at Screening (Visit 1) or Baseline (Visit 2).
- •3. QTc interval of 470 msec or greater at Screening (Visit 1).
- •4. Predominant stress urinary incontinence versus urge urinary incontinence based on subject history. Note: Determination to be made based on number of episodes of incontinence related to stress and urgency during the 7 days prior Baseline (Visit 2). If subject has more stress incontinence episodes than urge incontinence episodes, the subject will be excluded.
- •5. Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis, etc.).
- •6. Post micturition volume of >100 mL at baseline assessment.
- •7. Maximum bladder capacity > 450 mL at baseline assessment.
- •8. Anatomic or structural abnormalities possibly causing urinary incontinence or urgency, including but not limited to urogenital prolapse stage 2 or more according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
- •9. Current UTI or frequent UTIs (i.e., =4 UTIs per year), interstitial cystitis, hematuria unknown cause, or use of indwelling catheter.
- •10. Urological or gynecological surgery within 3 months of the baseline urodynamic assessment; cystoscopy within 30 days of the baseline urodynamic assessment.
- •11. Electro-stimulation therapy, bladder training, or physiotherapy for bladder control within 2 weeks of Screening (Visit 1).
- •12. History (within 1 year of Screening) of alcohol or substance dependence (except nicotine dependence) according to DSM-IV-TR criteria.
- •13. History of any kind of cancer within the last 2 years.
- •14. Existing non-malignant tumors that could compromise the function and/or anatomy of the lower urinary tract.
- •15. Subjects who have taken any prohibited medications within two weeks of baseline (Visit 2) or have any anticipated need or intended use of these medications during the study. Prohibited medications include, but are not limited to, oxybutynin, tolterodine, duloxetine, trospium chloride, darifenacin, solfenacin, and herbal preparations.
- •16. Participation in any clinical trial within the past 3 months (for investigational drugs, products, or devices).
- •17. Subjects who have previously received AV608 (previously known as NKP-608).
- •18. Positive result on urine testing for drugs of abuse (cannabis, amphetamines, cocaine, and phenycylidine) at Screening (Visit 1).
- •19. Any past or present history of liver disease (with the exception of history of hepatitis A) or renal failure (creatinine clearance < 60 cc/minute).
- •20. Current hypothyroidism or hyperthyroidism or laboratory findings consistent with thyroid dysfunction. Subjects who are being treated for thyroid disorder are eligible if they have been on stable doses of thyroid hormone for at least 6 months prior to Screening (Visit 1) and are currently euthyroid.
- •21. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
- •22. Members of the investigative staff or their families.
研究者
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