CTRI/2021/12/038596已完成3 期
A Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Active Control, Comparative Phase III Study to Evaluate the Efficacy, Safety of Fesoterodine Fumarate Extended Release Tablets 4 mg / 8 mg Versus Solifenacin Succinate Tablets 5 mg/10 mg in Adult Patients Diagnosed with Overactive Bladder with Symptoms of Urge Urinary Incontinence, Urgency, and Frequency.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female subjects aged 18 to 65 years (both inclusive) with a confirmed diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency (including micturitions greater than equals to 8 per day and urinary urgency episodes greater than equals to 1 per day)
- •2. Subjects willing to give voluntarily their written informed consent to participate in the study before being screened for the study.
- •3. Able to adhere to the study visit schedule and other protocol requirements.
- •4. All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study or be celibate or their partner must have had a vasectomy. The screening urine pregnancy tests should be negative (if the urine pregnancy test is positive, a serum pregnancy test should be performed, and the result should be negative). Women who have been surgically sterilized or are at least two years menopausal may be enrolled and do not need to use birth control.
排除标准
- •1. Subject having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse
- •2. Contraindications to fesoterodine (e.g. bladder outlet obstruction, narrow angle glaucoma, myasthenia gravis, severe hepatic or renal impairment)
- •3. Subject having Urinary retention requiring catheterization.
- •4. Subject having symptomatic, untreated urinary tract infection not resolved prior to starting fesoterodine.
- •5. Subject taking Botulinum toxin injection for Urgency Urinary Incontinence (UUI) in the last year.
- •6. Current therapy with peripheral or sacral neuromodulation.
- •7. Neurologic conditions that may affect urinary function (stroke, multiple sclerosis, spinal cord injury, Parkinsons disease).
- •8. Subjects with significant cardiac disorder (e g cardiac valve disease requiring specific treatment, pericardial constriction, Life threatening arrhythmia, uncontrolled hypertension, Acute myocardial infarction, permanent atrial fibrillation).
- •9. Subjects with severe renal insufficiency or ongoing or planned dialysis.
- •10. Subjects with documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin greater than 3 times of ULN accompanied by AST greater than of ULN (assessed by central laboratory at screening) and or Child-Pugh Class C.
- •11. Serum AST and or ALT greater than 3 times of ULN (assessed by centrallaboratory at screening). 12. Women of childbearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study.
- •13. Men who are unwilling to use contraception while receiving Fesoterodine.
- •14. Prior treatment with Fesoterodine.
- •15. Known or suspected hypersensitivity to Fesoterodine or any other component of the formulation.
- •16. Failure to control systemic fungal, bacterial or viral infection.
- •17. Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection.
- •18. Subjects with suspected signs and symptoms of COVID-19 or confirmed novel coronavirus infection COVID-19 or with a recent history of travel or contact with any COVID-19 positive subject or isolation or quarantine in last 14 days.
- •19. Have a history of neurological or psychiatric disorders, including epilepsy or dementia.
研究者
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