| CTRI Number |
CTRI/2022/06/043443 [Registered on: 22/06/2022] Trial Registered Prospectively |
| Last Modified On: |
12/11/2022 |
| 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 study of Alfuzosin and Tadalafil Combination Tablets in treatment of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). |
|
Scientific Title of Study
|
A Phase III, Multi-Centre, Double-Blind, Randomised, Parallel-Group, Active-Controlled Trial to compare Efficacy and Safety of Fixed Dose Combination of Alfuzosin 10 mg/10 mg ER plus Tadalafil 2.5 mg/5 mg Tablets versus Alfuzosin 10 mg ER Tablets in Patients with Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AKPL/FDC/AT/02/18; Version 1.0; Date 19.02.2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
91-80-35104561 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore
KARNATAKA
560078
India |
| Phone |
91-80-35104561 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore
KARNATAKA
560078
India |
| Phone |
91-80-35104561 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
|
Source of Monetary or Material Support
|
| Akums Drugs & Pharmaceuticals Limited |
|
|
Primary Sponsor
|
| Name |
Akums Drugs Pharmaceuticals Limited |
| Address |
Plot No. 131 to 133, Block –C Mangolpuri Industrial Area, Phase –I, New Delhi -110083. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajeev Sood |
ABVIMS & Dr RML Hospital |
Room no 31
Urology Department
ABVIMS & Dr RML Hospital
OPD Building
Dr RML Hospital
Delhi 110001
Central
DELHI |
9810005182
drsoodr@gmail.com |
| Dr Vinay Kumar |
GSVM Medical College |
Department of Surgery, LLR Hospital, GSVM Medical COllege, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH |
9839072553
vinaysinghkgmc99@gmail.com |
| Dr Prakash H S |
K R Hospital |
Department of Urology,
K R Hospital attached to Mysore Medical college and Research Institute,Irwin Road, Mysore 570001
Mysore
KARNATAKA |
9880840543
drhsprakash@gmail.com |
| Dr Apul Goel |
King Georges Medical College Medical University |
Department of Urology, King Georges Medical College Medical University, Shah Mina Road, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH |
9839181465
drapul.goel@gmail.com |
| Dr Ranjan Kumar Dey |
Lifeline Diagnostic Centre Cum Nursing Home |
Department of Urology,Lifeline Diagnostic Centre Cum Nursing Home, 4A, Wood Street, Kolkata- 700016
Kolkata
WEST BENGAL |
9831046873
ranjankdey@rediffmail.com |
| Dr Ashok Kumar Gupta |
Maharaja Agrasen Hospital |
Department of Urology, Maharaja Agrasen Hospital, West Punjabi Bagh,
New Delhi- 110026
West
DELHI |
9810046353
akg.urogyn@gmail.com |
| Dr Narasimhaswamy P |
Mandya Institute of Medical Sciences |
Department of Urology, 1st Floor, Mandya Institute Of Medical Sciences, Mandya, Bangalore-Mysore Road, Mandya,Karnataka-571401
Mandya
KARNATAKA |
9980867647
nswamy87@gmail.com |
| Dr Tapan Kumar Mandal |
Nil Ratan Sircar Medical College & Hospital |
Department of urology, Nil Ratan Sircar Medical College & Hospital,138 AJC Bose Road,
Kolkata- 700014
Kolkata
WEST BENGAL |
9830367795
drtapanmondal@yahoo.in |
| Dr Shabbir H Raja |
Orthonova Hospital Pvt Ltd |
Department of Urology, 22nd Floor, Lal Imli Chowk, Gandhibagh, Nagpur-02
Nagpur
MAHARASHTRA |
9920195352
shabbirrazakhan03@gmail.com |
| Dr Nipun A C |
Rajalakshmi Hospital & Research Centre |
Department of Urology, 21/1 Lakshmipura main road, Vidyaranyapura Post
Bangalore
560097
Bangalore
KARNATAKA |
9620438767
adrnipun@gmail.com |
| Dr Abhay Mahajan |
Sai Urology Hospital |
Department of Urology, Sai Urology Hospital
Vishal Nagar
Gajanan Mandir road
Aurangabad 431005
Aurangabad
MAHARASHTRA |
9822321224
drabhaymahajan@gmail.com |
| Dr Maneet Singh |
Vidhya Hospitals & Trauma Centre |
Department of Urology, Harikansgadi Mohanlalganj Raebareli Road
Lucknow
Lucknow
UTTAR PRADESH |
9792957585
drmanmeetsingh2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| ABVIMS & Dr. RML Hospital Ethics Committee |
Submittted/Under Review |
| Ethics Committee GSVM Medical College, Room No.125,1st Floor,Principal Office, Swaroop Nagar, Kanpur- 208002 |
Submittted/Under Review |
| HCG NCHRI CANCER CENTRE IEC HCG NCHRI CANCER CENTRE Kh.no. 50/51,Mouja Wanjari, Bande Nawaz Nagar Near Automotive Square, Kalamna,Ring Road Nagpur Maharashtra - 440026 India |
Submittted/Under Review |
| Institutional Ethics Committee Lifeline Diagnostic Centre Cum Nursing Home |
Submittted/Under Review |
| Institutional Ethics Committee Mysore Medical College & Research Institute & Associated Hopsitals |
Submittted/Under Review |
| Institutional Ethics Committee Nil Ratan Sircar Medical College & Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Research Cell Administrative Block, KGMU,Lucknow-226003 |
Submittted/Under Review |
| Maharaja Agrasen Hospital Institutional Ethics Committee |
Approved |
| Mandya Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Rajalakshmi Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Sai Urology Hospital, Ethics Committee |
Submittted/Under Review |
| Vidhya Hospital And Trauma Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alfuzosin 10 mg ER Tablets |
The recommended dosage is one tablet of Alfuzosin 10 mg ER Tablets orally once daily, in the morning after breakfast for 24 weeks of treatment duration. |
| Intervention |
Fixed dose combination of Alfuzosin 10 mg ER plus Tadalafil 5 mg Tablets |
The recommended dosage is one tablet of FDC of Alfuzosin 10 mg ER plus Tadalafil 5 mg Tablets oforally once daily, in the morning after breakfast for 24 weeks of treatment duration. |
| Intervention |
Fixed-dose combination of Alfuzosin 10 mg ER plus Tadalafil 2.5 mg Tablets |
The recommended dosage is
one tablet of FDC of Alfuzosin 10 mg ER plus Tadalafil 2.5 mg Tablets oforally once daily, in the morning after breakfast for 24 weeks of treatment duration. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
1. Men aged 45 or older.
2. Clinical signs and symptoms of BPH for ≥6 months.
3. Moderate to severe LUTS at screening, as defined by International Prostate Symptom Score (IPSS) >13.
4. An IPSS QoL score of >3 at screening.
5. Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume >125 mL at screening.
|
|
| ExclusionCriteria |
| Details |
1. Stone in the bladder or urethra causing symptoms.
2. Acute or chronic prostatitis.
3. Documented history of Interstitial cystitis/painful bladder syndrome.
4. Patients who had failed treatment with finasteride.
5. Patients with Prostate Specific Antigen (PSA) beyond 4 ng/ml at screening.
6. Hypersensitivity towards any component of the investigational medicinal product (IMP).
7. Patients previously not improved by an alpha1-blocker treatment.
8. Acute or recurrent urinary tract infections.
9. Patients with history of prostate cancer.
10. History of acute urinary retention (AUR).
11. History of any of the following pelvic conditions:
• Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery.
• Pelvic radiotherapy.
• Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies.
• Lower tract malignancy or trauma.
12. Clinically significant microscopic haematuria at screening.
13. Any causes other than BPH, which may affect the evaluation of symptoms of urine flow (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, and bladder malignancy) as judged by the Investigator.
14. Any clinically significant disorder (other than BPH) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, or any other condition, which may affect the patients health, or the outcome of the trial as judged by the Investigator.
15. Diagnosed cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin.
16. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
17. Mental incapacity or language barrier precluding adequate understanding or co-operation.
18. History or current evidence of drug, alcohol, or substance abuse within 6 months prior to screening.
19. Previous participation in any Alfuzosin and tadalafil or any relevant clinical trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Change in Total International Prostate Symptom Score (IPSS) from baseline to each visit. |
Mean Change in Total International Prostate Symptom Score (IPSS) from baseline to each visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Change in IPSS Voiding subscore (Question 3, 5, 6 of IPSS) from baseline to each visit. |
Baseline (Day 0), Visit 3 (Day 28±2), Visit 4 (Day 56±2), Visit 5 (Day 84±2) |
| Mean Change in IPSS storage subscore (Question 2, 4, 7 of IPSS) from baseline to each visit. |
Baseline (Day 0), Visit 3 (Day 28±2), Visit 4 (Day 56±2), Visit 5 (Day 84±2) |
| Mean Change in IPSS postmicturition subscore (Question 1 of IPSS) from baseline to each visit. |
Baseline (Day 0), Visit 3 (Day 28±2), Visit 4 (Day 56±2), Visit 5 (Day 84±2) |
| Mean Change in Maximum Urinary Flow Rate (Qmax) at the end of study visit compared to baseline visit. |
Baseline (Day 0), Visit 5 (Day 84±2) |
| Mean change in urine flow rate (Qmean) at the end of study visit compared to baseline visit. |
Baseline (Day 0), Visit 5 (Day 84±2) |
| Mean change in IPSS QoL Index Score at the end of study visit compared to baseline visit. |
Baseline (Day 0), Visit 5 (Day 84±2) |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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)
|
30/06/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, double blind, multicentre, active controlled, comparative, parallel group, phase III clinical study in patient with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in Indian population.
Laboratory assessments (Haematology and Biochemistry) shall be performed on screening and end of study visit.
Patients will be provided with subject diary to record details about study drug administration, rescue medication, and adverse events. Patients will be required to bring completed diary at each visit. At randomization/baseline visit, subjects shall be randomly (Double blind) assigned in 1:1:1 fashion to one of the three treatment groups for 12 weeks. Those subjects who do not meet the inclusion/exclusion criteria will be considered as screen failures. The randomized subjects will be provided with study medication and asked to follow up for further visits till 12 weeks post randomization.
Patients will be instructed to administer one tablet of test products or comparator product orally once daily, in the morning after breakfast for 12 weeks of treatment duration.
After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study.
Following are the Study Visit Details:
• Visit 1: Screening Visit (Days -7 to Day -1) • Visit 2: Randomization/Baseline Visit (Day 0) • Visit 3: Follow-up Visit (Week 4/Day 28 ± 2 days) • Visit 4: Follow-up Visit (Week 8/Day 56 ± 2 days) • Visit 5: End of Study/Early Discontinuation Visit (Week 12/Day 84 ± 2 days) |