CTRI/2019/08/020935已完成3 期
A multi-centric, randomized, double blind, parallel group, active controlled, comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Mirabegron 25mg/50mg (ER) plus Solifenacin succinate 5mg/5mg tablet versus Mirabegron 25mg/50mg (ER) tablet, Solifenacin succinate 5mg tablet in subjects diagnosed with Overactive bladder.
Windlas Biotech Pvt Ltd0 个研究点目标入组 176 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
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
- •Subjects who meet the following criteria are eligible for inclusion in
- •1.Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form.â?¨
- •2.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements.â?¨
- •3.Female and Male (both) patients of age >=18 to <=65years.â?¨
- •4.Patients having symptoms of OAB (urinary frequency and urgency with or without urge incontinence) for 3 months.â?¨
- •5.Patients diagnosed with OAB based on scores 1 in the URGENCY Questionnaire.â?¨
- •6.Patients diagnosed with OAB based on scores 3 in the OABSS Questionnaire.â?¨
- •7.Patients not treated with anticholinergics.â?¨
- •8.Washout period of 15 days when the patient is receiving anticholinergics.
排除标准
- •1.Patients with urinary tract infections.â?¨
- •2.Patients with renal calculi.â?¨
- •3.Patients with renal tumours , bladder cancer or prostate cancer
- •4.Patients with urinary retention.
- •5.Residual urine volume >100 mL (determined by abdominal sonography)â?¨
- •6.Patients with reduced gastrointestinal motility.â?¨
- •7.Patients with myasthenia gravis.â?¨
- •8.Patients with narrow angle glaucoma.â?¨
- •9.Patients with occluded pyloric region or paralytic ileus gastric and intestinal atony.â?¨
- •10.Patients with contraindications to anticholinergic drugs.
- •11.Clinically relevant or unstable cardiovascular diseases or hypertensive patient diagnosed with systolic blood pressure >= 180mm Hg and/or diastolic blood pressure >= 110mm Hg). â?¨
- •12.Type 1 or poorly controlled type 2 diabetes mellitus (haemoglobin A1c: >9%).â?¨
- •13.Patients with neurologic disorders (e.g., multiple sclerosis, disk herniation, stroke, or diabetes) or previous urogenital operations (e.g., radical prostatectomy, transurethral resection).â?¨
- •14.Patients with history of drug or alcohol abuse.â?¨
- •15.Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study.â?¨
- •16.Patient has undergone administration of any investigational drug within 30 days of study initiation.â?¨
- •17.Patient has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
研究者
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