EUCTR2006-003730-15-LT进行中（未招募）不适用
A 10-week randomised, double-blind, parallel-group, placebo-controlled phase 2 study to investigate the extent of symptom relief and the safety and tolerability of SMP-986 (20 mg, 40 mg, 80 mg and 120 mg) administered once daily for 8 weeks to patients with overactive bladder syndrome - SMP-986 phase 2 proof of concept in patients with OABS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 710
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
- •To be eligible for inclusion patients must:
- •1. Have given written informed consent to participate in the study
- •2. Be>= 20=< 80 years of age (at screening). Female subjects must meet one of the following criteria:
- •Be postmenopausal as defined by the following
- •- Either >= 12 months of spontaneous amenorrhea or >= 6 - =< 12 months of spontaneous amenorrhea with FSH levels within the post menopausal range as determined by the central laboratory
- •- Surgically sterile
- •Be prepared to use a highly effective non-oral form of contraception during the course of the study and for 3 months after the last dose of study drug. The use of implants or injectables as a form of contraception is excluded. A pregnancy test will be performed at screening in women of childbearing potential.
- •3. Have a documented diagnosis of OABS based on symptomatic reporting of urinary frequency and urgency (with or without urgency incontinence) over a successive period of >= 6 months prior to screening
- •4. Have had an average of >= 8 micturition episodes/ 24 hrs during the 3 days prior to randomisation
- •5. Have experienced >= 3 episodes of urgency with or without urgency incontinence during the 3 days prior to randomisation
- •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
- •Patients are not eligible for this study if they fulfil any of the following criteria:
- •1. Have a cardiac arrhythmia that requires treatment
- •2. Have a post-void residual volume >150 mL at screening
- •3. Have a maximum urine flow rate of <15mL/s at screening or at visit 2 (applicable to male patients only)
- •4. Have, or have had, a medical condition contraindicating the use of antimuscarinics (e.g. untreated narrow angle glaucoma, uncontrolled open angle glaucoma, xerostomia, myasthenia gravis) or a known hypersensitivity to anti-cholinergics
- •5. Have not discontinued use of the following prohibited medications from >= 14 days prior to randomisation: any drugs used to treat OABS or urinary incontinence, cholinergics, anti cholinergics, alpha adrenergic antagonists, opioid analgesics, compound analgesics containing an opioid, warfarin or other substrates of cytochrome P450 2C9 which have a narrow therapeutic index, potent cytochrome P450 3A4 and 2D6 inhibitors or inducers
- •6. Are not willing or able to complete a study diary during the 8-week study (patients capabilities’ in this respect will be assessed by the clinical site staff using patients’ diary data from the placebo run-in phase)
- •7. Have a drug compliance of <= 80 % for the placebo run-in period
- •8. Continued use of the following prohibited treatments from >= 14 days prior to screening: electro-stimulation therapy for OABS, bladder training programme if not stabilised before screening
- •9. Have an indwelling catheter or perform intermittent self catheterisation
- •10. Have participated in another clinical trial with an investigational drug within 8 weeks prior to randomisation
- •11. Have polyuria (a documented medical history and/or a study diary recording of an average of >= 3L urine passed/ 24 hrs during the 3 days prior to randomisation)
- •12. Have stress urinary incontinence or mixed urinary incontinence for which stress is the predominant factor
- •13. Have a neurological cause of OABS symptoms e.g. multiple sclerosis, Parkinson’s disease, full or partial spinal cord injury
- •14. Have painful bladder syndrome/interstitial cystitis, bladder stones or a symptomatic calculous disease (e.g. kidney stones) affecting the lower urinary tract
- •15. Have poorly controlled diabetes as indicated by an HbA1c result of >7% at screening
- •16. Have a documented past medical history of peripheral, autonomic or diabetic neuropathy
- •17. Have ever received any specialist pharmacological treatment for OABS e.g. treatment with botulinum toxin A, resiniferatoxin or capsaicin
- •18. Have a urinary tract infection (UTI) or, have had proven diagnoses of >= 3 episodes of UTI within the 12 months prior to screening
- •19. Have, or have had a malignancy with or without metastases within the last 5 years or have ever had a malignant tumour affecting the genitourinary tract or who currently have benign prostatic hyperplasia with bladder outlet obstruction
- •20. Have had genitourinary surgery or lower bowel surgery within the 12 months prior to screening or have ever received pelvic radiation
- •21. Have >= stage 2 pelvic organ prolapse (as defined by the ICS pelvic organ prolapse quantification system)
- •22. Concomitant use of hormone replacement therapy or diuretics if the dose has not been stable for a period of >= 12 weeks prior to screening
- •23. Have, in the opinion of the Investigator, a significant history of constipation or have an active bowel disease (e.g. inflammatory bowel disease, colitis, d
研究者
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