Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: FDC of Mirabegron(ER) 25/50mg and Solifenacin succinate 5mg tablet: Mirabegron (ER)25mg plus Solifenacin succinate 5mg Tablet once a day orally. or
Mirabegron 50(ER) plus Solifenacin
Sponsors
Windlas Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet the following criteria are eligible for inclusion in the study: 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 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.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable sought in the protocol is the clinical outcome in score of OABSS achievedTimepoint: Day (-3 to -1), Day 1, Day 15, Day 30, Day 60, Day 90, Day 105 | — |
Secondary
| Measure | Time frame |
|---|---|
| will be evaluated by the following variablesTimepoint: 1. Changes from baseline to end of treatment visit in number of urge urinary incontinence, urgency, and urinary frequency per 24 hours in day-timeâ?¨ 2. Changes from baseline to end of treatment visit in numbers of urge urinary incontinence, urgency, and urinary frequency per 24 hours in night-time | — |
Countries
India
Contacts
Public ContactMukesh Kumar
RAHE LIFE SCIENCE
Outcome results
None listed