A clinical study to see the effect and safety of Fixed Dose Combination of Silodosin and Solifenacin Capsules in Comparison to Silodosin Capsules in Male Patients Having Benign Prostatic Hyperplasia (BPH)/ Lower Urinary Tract Symptoms (LUTS) with Over Active Bladder (OAB)

Phase 3

Not yet recruiting

• Conditions: Bladder disorders in diseases classified elsewhere,

• Registration Number: CTRI/2020/07/026419
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

This is a randomized, multi-centric, double blind,double dummy, active controlled, parallel, comparative study. The study will beconducted at approximately 12-18 centers in India, having qualifiedInvestigators. The study will be initiated only after the receipt of regulatoryand ethics committee (EC) approval. The total duration of study will be 16weeks, which includes 04 weeks (maximum) of screening period [inclusive of 07days Run-in period and 14 days washout period (only for patient taking alpha blockerother than Silodosin)] and 12 weeks of treatment period.

After obtaining the informed consent, patients willbe screened by undergoing various assessments as mentioned in Schedule ofAssessment (Appendix I), eligible patients will be instructed to continue alphablocker at the prescribed dose for 07 days of run-in period. Also, patientswill be provided with a 07 days bladder diary to record the micturitionfrequency and urgency episodes, for at least 3 days during run-in period and hewill be instructed to visit the site after 07 days of run-in period. Afterassessing bladder diary, if number of micturitions are ≥ 8 times per 24 hourswith at least 2 urgency episodes per 24 hours for at least 3 days then,baseline assessments (Total IPSS, IPSS Storage, IPSS Voiding, IPSS- QoL,Uroflowmetry and PVR) will be performed as mentioned in Schedule of Assessments(Appendix I). Patient will undergo washout period of 14 days if he was on alphablocker other than Silodosin, otherwise washout is not required in patienttaking Silodosin.

After this, eligibility criteria of patients willbe confirmed based on various assessments as mentioned in Schedule ofAssessments (Appendix I). Further, eligible patients will be randomized toeither FDC of Silodosin + Solifenacin Succinate (8 mg + 5 mg) group orSilodosin 8 mg group in the double blind fashion and patient will take theassigned medication for 12 weeks.

Patient will be instructed to fill the bladder diary for at least 3 dayswithin 07 days prior to coming for Visit 03, 04 and 05.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-09
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 266

Inclusion Criteria

1.Male patient, aged between 50 to 75 years (both inclusive), having Benign Prostatic Hyperplasia (BPH)/ Lower Urinary Tract Symptoms (LUTS) and with residual Over Active Bladder (OAB) symptoms despite treatment with Silodosin 8 mg or other alpha blockers (Alfuzosin 10 mg, Tamsulosin 0.4 mg) for more than equal to 4 weeks prior to screening 2.Patient with total IPSS more than equal to 13 with urgency item score more than 1 during screening 3.Patient with IPSS-QoL item score of greater than 2 during screening 4.Patient with number of micturitions more than equal to 8 times per 24 hours and at least 2 urgency episodes per 24 hours in a 3 day bladder diary during screening 5.Patient with Post Void Residual (PVR) volume less than equal to 150 ml and maximum urinary flow rate (Qmax) between 5 to 15 mL/s during screening 6.Patient is willing to give informed consent 7.Patient must agree to use adequate contraception from study entry till the last dose of the study medication.

Exclusion Criteria

• 1)Patient taking anti-muscarinics (other than Solifenacin), antispasmodics, any substances to influence voiding function at the time of screening or planning to take during study 2)Patient with history of prostate cancer and/or previous prostatic/ bladder neck surgery 3)Patient with history of urethral obstruction due to stricture, valves, sclerosis or tumour and patient with previous urethral surgery 4)Patient with autonomic neuropathy, neurologic bladder conditions (e.g. multiple sclerosis, spinal cord injury, Parkinson disease) 5)Patient with clinically significant bladder outflow obstruction other than BPH, as judged by investigatorPatients receiving Miconazole.
• 6)Patient with chronic inflammation, bladder stones, bladder neck stricture, sclerosis, severe vesical diverticulum, urethral stricture 7)Patient with history of cancer or undergoing chemotherapy 8)Patient with history of severe cardiac diseases, including angina requiring certain treatment with nitrates or any clinically significant conditions 9)Patient with a history of esophageal or intestinal or gastric pylorus obstruction or gastrointestinal disorders (including gastric retention and toxic megacolon) which is associated with decreased gastrointestinal motility at the time of screening 10)Patient with hiatus hernia/gastro-oesophageal reflux and/or who is concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis 11)Patient with irradiation to the pelvis, interstitial cystitis, prostatitis 12)Patient who is likely to require catheterization within next 3 months 13)Patient with history of symptomatic orthostatic hypotension or recurrent dizziness, vertigo, loss of consciousness or syncope 14)Patient with history of any condition that is a contraindication for anticholinergic treatment including narrow angle glaucoma, urinary retention and myasthenia gravis 15)Patient who started with a 5-alpha reductase inhibitor within 3 months prior to screening or planning to take during the study 16)Patient undergoing haemodialysis 17)Patient with symptomatic acute Urinary Tract Infection (UTI) during the screening period or recurrent UTI (more than equal to 2 episodes within the last 6 months from the screening) 18)Patient with moderate to severe renal impairment (Creatinine clearance less than 50 mL/min) and severe hepatic impairment (AST and ALT more than 3 x ULN) 19)Patient with serum Prostate Specific Antigen (PSA) beyond 4 ng/ ml at screening 20)Patient with uncontrolled hypertension (BP more than equal to 140/90 mm of Hg) and type 2 diabetes (HbA1c more than 9%) 21)Patient has a clinically significant disorder that, in the opinion of the investigator, would result in the patient’s inability to understand and comply with the requirements of the study 22)Patient with history of HIV and/or Hepatitis B and/or Hepatitis C 23)Patient with history of angioedema with airway obstruction 24)Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 25)Patient planning cataract surgery during the study 26)Patients having history of QT prolongation or patients who are taking medications known to prolong QT interval 27)Patient using any nitrates, androgens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/ antagonists, PDE5 inhibitors, anabolic steroids, verapamil, antiandrogens, diuretics, cholinergics, anti-cholinergics and phytotherapy or other drugs which affects prostate volume, at screening or planning to take during study 28)Patient using strong Cytochrome P4503A4 inhibitors (ketoconazole, clarithromycin, itraconazole, ritonavir etc) or Strong P-glycoprotein inhibitors (e.g., cyclosporine, verapamil, erythromycin etc.) at the time of screening or during study 29)Patient having hypersensitivity or any other contraindication to any of the Investigational products including its components 30)Patient with known alcohol or other substance abuse within last one year as per DSM – 5 criteria 31)Patient involved in professions like driving, operating heavy machinery or performing hazardous work 32)Patient who has participated in another investigational study within 3 months prior to screening in this study 33)Investigator’s, study personnel, sponsor’s representatives and their first degree relatives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in IPSS Storage subscore from baseline	[Time frame: 4, 8 and 12 weeks]

Secondary Outcome Measures

Name	Time	Method
Change in Total International Prostate Symptom Score (IPSS) from baseline	[Time frame: 4, 8 and 12 weeks]
Change in mean number of micturitions per 24 hrs from baseline	[Time frame: 4, 8 and 12 weeks]
Change in mean number of urgency episodes per 24 hrs from baseline	[Time frame: 4, 8 and 12 weeks]
Change in post void residual volume from baseline	[Time frame: 12 weeks]
Change in IPSS Voiding (Obstructive) subscore from baseline	[Time frame: 4, 8 and 12 weeks]
Change in IPSS- QoL from baseline	[Time frame: 4, 8 and 12 weeks]

Trial Locations

Locations (15)

All India Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

Dr Ram Manohar Lohia Hospital & PGIMER; 🇮🇳 Delhi, DELHI, India

Gandhi Medical College/ Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Government medical college & super Speciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

King George’s Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lokmanya Tilak Municipal Medical College & General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Lotus Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Medical College Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

N.R.S. Medical College & Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Noble Hospitals Pvt.Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Scroll for more (5 remaining)

All India Institute of Medical Sciences

🇮🇳Khordha, ORISSA, India

Dr Prasant Nayak

Principal investigator

9494697071

prasantnyk@gmail.com