A Phase III, Randomised, 3-Arm Parallel Group, Double-Blind, Non-Inferiority, Active Controlled Multicentre Study to Evaluate and Compare the Efficacy and Safety of Mirabegron 25 mg ER tablet and 50 mg ER tablet with Tolterodine 4 mg ER tablet in Patients with Overactive Bladder.

MSN Laboratories Private Limited0 个研究点入组 312 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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Female/Male patients of age between 18-55 years
Patients having symptoms of OAB (urinary frequency and urgency with or without urge incontinence) for >= 3 months
Patients diagnosed with OAB based on scores >=1 in the URGENCY Questionnaire.
Patients diagnosed with OAB based on scores >=3 in the OABSS Questionnaire
Patients not treated with anticholinergics
Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form.
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
Washout period of 2 weeks when the patient is receiving anticholinergics

Patients with urinary tract infections
Patients with renal calculi
Patients with renal tumors , bladder cancer or prostate cancer
Patients with urinary retention
Residual urine volume >=100 mL (determined by abdominal sonography)
Patients with reduced gastrointestinal motility
Patients with myasthenia gravis
Patients with narrow angle glaucoma
Patients with occluded pyloric region or paralytic ileus gastric and intestinal atony
Patients with contraindications to anticholinergic drugs
Clinically relevant or unstable cardiovascular diseases
Type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c: >=9%).
Patients with neurologic disorders (e.g., multiple sclerosis, disk herniation, stroke, or diabetes) or previous urogenital operations (e.g., radical prostatectomy, transurethral resection)
History of drug or alcohol abuse
Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study.
Subject has undergone administration of any investigational drug within 30 days of study initiation.
Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided

发起方