CTRI/2020/07/026419 [Registered on: 07/07/2020] Trial Registered Prospectively
Last Modified On:
25/09/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
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)
Scientific Title of Study
A Randomized, Multi-Centric, Double Blind, Double Dummy, Active Controlled, Parallel, Comparative Study to Evaluate Efficacy 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)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ICR/19/003, Version No. 2.0; Dated 09/DEC/2019
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shilpi Dhawan
Designation
Head India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited,
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai-400063, Maharashtra, India.
Mumbai MAHARASHTRA 400063 India
Phone
02243245299
Fax
02243244343
Email
shilpi.dhawan@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Maulik Doshi
Designation
Medical Monitor
Affiliation
Sun Pharma laboratories Limited
Address
Sun Pharma laboratories Limited
Tandalja, Vadodara-390020
Gujarat
Vadodara GUJARAT 390020 India
Phone
02656612829
Fax
02652354897
Email
maulik.doshi@sunpharma.com
Details of Contact Person Public Query
Name
Guruprasad Palekar
Designation
Deputy General Manager
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited
Sun House,
201 B/1, Western Express Highway,
Goregaon (E),Mumbai 400 063
Mumbai MAHARASHTRA 400063 India
Phone
02243246215
Fax
02243244343
Email
guruprasad.palekar@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited
Sun House,
201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited
Sun House,
201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063
Department of Urology,
Sijua, Patrapada, Bhubaneswar-
751019, Odisha Khordha ORISSA
9494697071
prasantnyk@gmail.com
Prof Dr Rajeev Sood
Dr Ram Manohar Lohia Hospital & PGIMER
Department of Urology, Room no. 31, OPD Block, Dr Ram Manohar Lohia Hospital & PGIMER, Baba Kharag Singh Marg, New Delhi – 110001 (India)
Mobile Number: 9810005182
E-mail: drsoodr@gmail.com New Delhi DELHI
9810005182
drsoodr@gmail.com
Dr G Ravi Chander
Gandhi Medical College/ Hospital
In Patient block, 5th floor, Department of Urology, Gandhi Medical College/ Hospital, Musheerabad, Secunderabad, Telangana- 500003
Mobile No: 9989824032
Email ID: gatturavi69@gmail.com
Hyderabad TELANGANA
9989824032
gatturavi69@gmail.com
Dr Dhananjay V Selukar
Government medical college & super Speciality Hospital
Department of urology, Government medical college & super Speciality Hospital, Near Tukdoji Square, Nagpur 440009, Maharashtra, India
Mobile Number: 9225234197
E-mail: vazirgmc@gmail.com Nagpur MAHARASHTRA
9225234197
vazirgmc@gmail.com
Dr Prof S N Sankhwar
King George’s Medical University
Department of Urology, King George’s Medical University, Chowk, Lucknow-226003, Uttar Pradesh, India.
Mobile No: 7905487746
Email ID: sankhwarsn_sn@yahoo.com/ snsankhwar@kgmcindia.edu Lucknow UTTAR PRADESH
7905487746
sankhwarsn_sn@yahoo.com
Dr Sawant Ajit Somaji
Lokmanya Tilak Municipal Medical College & General Hospital
Department of Urology, 2nd Floor, College Building, Dr. Ambedkar Road, Sion Mumbai- 400022 Mumbai MAHARASHTRA
9833112612
drajits66@rediffmail.com
Dr Kunal Hemant Aterkar
Lotus Multispeciality Hospital
Lotus Multispeciality Hospital
Room No. 03, 2nd floor, Block N, Krupa Residency, Motera Stadium Road, Motera – Sabarmati, Ahmedabad-380005, Gujarat, India
Mobile Number: 9913777445
E-mail: lotushospital.cr@gmail.com Ahmadabad GUJARAT
9913777445
lotushospital.cr@gmail.com
Dr Malay Kumar Bera
Medical College Kolkata
Department of Urology, Medical College, Kolkata,
88, College Street, Kolkata-700073, West Bengal
Mobile Number: 9433007010
E-mail: beramalaykr@gmail.com Kolkata WEST BENGAL
9433007010
beramalaykr@gmail.com
Dr Tapan Kumar Mandal
N.R.S. Medical College & Hospital
138, AJC Bose
Road, Kolkata-
700014, West
Bengal Kolkata WEST BENGAL
9830367795
drtapanmondal@yahoo.in
Dr Shashikant Ramrao Bhange
Noble Hospitals Pvt.Ltd
OPD No.6, Ground Floor, Urology Department, Noble Hospitals Pvt.Ltd.,Pune-153, Magarpatta City Road, Hadapsar, Pune- 411013, Maharashtra, India Mobile Number:9657755927
E-mail Id: srbhange@yahoo.in Pune MAHARASHTRA
9657755927
srbhange@yahoo.in
Dr Pawan Kumar Jindal
Opal Hospital Private Limited
Opal Hospital Private Limited N. 10/60-2 DLW Rd, Kakarmatta Varanasi-221002 Uttar Pradesh INDIA
Mobile Number: 9415224411
E-mail : pkjindaldr@yahoo.co.in Varanasi UTTAR PRADESH
9415224411
pkjindaldr@yahoo.co.in
Dr Santosh Bukya
Osmania General Hospital
Department of Urology, Osmania General Hospital, Afzalgunj, Hyderabad- 500012, Telangana
Mobile No: 9866081600
Email ID: santudoc@gmail.com Hyderabad TELANGANA
9866081600
santudoc@gmail.com
DrChaudhari Hiralal Narottam
Oyster & Pearl Hospitals
Oyster & Pearl Hospitals,1671-75,Ganeshkhind Road,Shivajinagar,Pune-411005
Mobile Number: 9673997558
E-mail: dochira07@yahoo.co.in Pune MAHARASHTRA
9673997558
dochira07@yahoo.co.in
Dr Mahajan Pratikshit Madhav
Shree Siddhivinayak Maternity & Nursing Home
Shree Siddhivinayak Maternity & Nursing Home
Unity Campus, Opposite KTHM College, Gangapur Road, Nashik 422002, Maharashtra, India
Mobile Number. 9881058580
E-mail Id– pratikshitm@yahoo.com
Nashik MAHARASHTRA
9881058580
pratikshitm@yahoo.com
Dr Vinay Tomar
SMS Medical College and Attached Hospitals
Department of Urology SMS Medical College and Attached Hospitals, Jaipur-302004, Rajasthan, India
Mobile No: 9414057088
Email ID: dr_v_tomar06@yahoo.co.in
Jaipur RAJASTHAN
(1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
FDC of Silodosin 8 mg and Solifenacin Succinate 5 mg Capsule
Patient in both the arms will be asked to consume two capsules as a whole (of FDC of Silodosin and Solifenacin Succinate Capsule/ Silodosin Capsule and matching placebo of other) once daily with meal, at same time, preferably at night for total 12 weeks duration of therapy.
Comparator Agent
Silodosin Capsule 8 mg
Patient in both the arms will be asked to consume two capsules as a whole (of FDC of Silodosin and Solifenacin Succinate Capsule/ Silodosin Capsule and matching placebo of other) once daily with meal, at same time, preferably at night for total 12 weeks duration of therapy.
Inclusion Criteria
Age From
50.00 Year(s)
Age To
75.00 Year(s)
Gender
Male
Details
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.
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Change in IPSS Storage subscore from baseline
[Time frame: 4, 8 and 12 weeks]
Secondary Outcome
Outcome
TimePoints
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]
Target Sample Size
Total Sample Size="266" Sample Size from India="266" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/09/2020
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
NIL
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a randomized, multi-centric, double blind,
double dummy, active controlled, parallel, comparative study. The study will be
conducted at approximately 12-18 centers in India, having qualified
Investigators. The study will be initiated only after the receipt of regulatory
and ethics committee (EC) approval. The total duration of study will be 16
weeks, which includes 04 weeks (maximum) of screening period [inclusive of 07
days Run-in period and 14 days washout period (only for patient taking alpha blocker
other than Silodosin)] and 12 weeks of treatment period.
After obtaining the informed consent, patients will
be screened by undergoing various assessments as mentioned in Schedule of
Assessment (Appendix I), eligible patients will be instructed to continue alpha
blocker at the prescribed dose for 07 days of run-in period. Also, patients
will be provided with a 07 days bladder diary to record the micturition
frequency and urgency episodes, for at least 3 days during run-in period and he
will be instructed to visit the site after 07 days of run-in period. After
assessing bladder diary, if number of micturitions are ≥ 8 times per 24 hours
with 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 alpha
blocker other than Silodosin, otherwise washout is not required in patient
taking Silodosin.
After this, eligibility criteria of patients will
be confirmed based on various assessments as mentioned in Schedule of
Assessments (Appendix I). Further, eligible patients will be randomized to
either FDC of Silodosin + Solifenacin Succinate (8 mg + 5 mg) group or
Silodosin 8 mg group in the double blind fashion and patient will take the
assigned medication for 12 weeks.
Patient will be instructed to fill the bladder diary for at least 3 days
within 07 days prior to coming for Visit 03, 04 and 05.