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
- 试验地点
- 10
- 主要终点
- Number of Micturitions Per 24 Hours
研究概览
简要总结
This will be a double blind, prospective, multi-centre, two arms, active control study to evaluate safety and efficacy of Fesoterodine fumarate extended release tablets 4mg/8 mg and compare with Solifenacin succinate tablets 5 mg/10 mg in subjects with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Initially, subjects who require treatment with Fesoterodine and Solifenacin will be screened as per predefined eligibility criteria for the study. Eligible 216 subjects (108 per arm) will be enrolled to receive treatment with either Fesoterodine fumarate extended-release tablets of M/s.MSN laboratories private limited or Solifenacin tablets for 12 weeks. Each subject randomized to test group will receive Fesoterodine fumarate Extended Release Tablets orally once daily and subjects randomized to reference group will receive Solifenacin succinate tablets once daily.
At 4 weeks or 8 weeks, subjects will have dose titration based on investigator discretion for the Fesoterodine dose from 4 mg to 8 mg based on treatment response and tolerability as per investigator discretion. Similarly, subjects on Solifenacin succinate tablets will have dose titration from 5 mg to 10 mg at week 4 or week 8 as per investigator discretion. Subjects will initiate with a dose of 4mg till the 4th week. If the subject is responding well to 4mg, they will continue on 4mg till 8th week (total 8 weeks) or till EOS (total 12 weeks).
Based on the treatment response and tolerability, the dose may be escalated to 8mg during the week 4 visit. The subject will continue on 8mg till EOS (total 8 weeks). There will be no de-escalation of dose. If the drug is not tolerated, the subject will be excluded from the study. Similarly, the dose may be escalated from 4mg to 8mg on week 8 visit. The subject will continue on 8mg till EOS (total 4 weeks). The same method will be followed for the comparator group for escalation from 5mg to 10mg on Week 4 or Week 8 visit.
Efficacy analysis will be conducted in per-protocol subjects and the safety analysis will be conducted in all randomized subjects. All subjects in this study will be assigned in ratio of 1:1 respectively to the test and comparator product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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)
- •Subjects willing to give voluntarily their written informed consent to participate in the study before being screened for the study.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •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).
排除标准
- •Subject having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse
- •Contraindications to fesoterodine (e.g. bladder outlet obstruction, narrow angle glaucoma, myasthenia gravis, severe hepatic or renal impairment)
- •Subject having Urinary retention requiring catheterization.
- •Subject having symptomatic, untreated urinary tract infection not resolved prior to starting fesoterodine.
- •Subject taking Botulinum toxin injection for Urgency Urinary Incontinence (UUI) in the last year.
- •Current therapy with peripheral or sacral neuromodulation.
- •Neurologic conditions that may affect urinary function (stroke, multiple sclerosis, spinal cord injury, Parkinsons disease).
- •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).
- •Subjects with severe renal insufficiency or ongoing or planned dialysis.
- •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.
- •Serum AST and or ALT greater than 3 times of ULN (assessed by centrallaboratory at screening).
- •Women of childbearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study.
- •Prior treatment with Fesoterodine.
- •Known or suspected hypersensitivity to Fesoterodine or any other component of the formulation.
- •Failure to control systemic fungal, bacterial or viral infection.
- •Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection.
- •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.
- •Have a history of neurological or psychiatric disorders, including epilepsy or dementia.
结局指标
主要结局
Number of Micturitions Per 24 Hours
时间窗: week 4, week 8 and week 12
次要结局
- Number of Urgency Episodes per 24 Hours(week 4 and week 8 and week 12)
- Number of UUI Episodes Per 24 Hours(week 4 and week 8 and week 12)
- Number of Number of Nighttime Micturitions Per 24 Hours(week 4 and week 8 and)
- Safety Assessments(week 4, week 8 and week 12)