| CTRI Number |
CTRI/2020/07/026440 [Registered on: 08/07/2020] Trial Registered Prospectively |
| Last Modified On: |
07/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [THERAPEUTIC] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluate efficacy and safety of combination of Silodosin and Tadalafil vs. Silodosin or Tadalafil alone in patients with enlarged prostate |
|
Scientific Title of Study
|
Efficacy and safety of combination of Silodosin and Tadalafil vs. Silodosin or Tadalafil alone in patients with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH): An open label randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rudra Prasad Ghorai |
| Designation |
Senior Resident, Department of Urology, AIIMS Rishikesh |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Urology, Level 6, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9874230282 |
| Fax |
|
| Email |
dr.rudraghorai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kim Jacob Mammen |
| Designation |
Professor, Department of Urology, AIIMS Rishikesh |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Urology, Level 6, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9814034185 |
| Fax |
|
| Email |
kjmammen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rudra Prasad Ghorai |
| Designation |
Senior Resident, Department of Urology, AIIMS Rishikesh |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Urology, Level 6, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9874230282 |
| Fax |
|
| Email |
dr.rudraghorai@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NONE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rudra Prasad Ghorai |
AIIMS Rishikesh |
Department of Urology, Level 3, AIIMS Rishikesh, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL |
9874230282
dr.rudraghorai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH INSTITUTIONAL 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 |
| Intervention |
Combination of Tablet Silodosin and Tablet Tadalafil |
Combination of tab Silodosin 8mg and Tab Tadalafil 5mg once daily orally at bedtime for 12 weeks |
| Comparator Agent |
Tablet Silodosin 8 mg |
Tablet Silodosin 8mg once daily orally at bedtime for 12 weeks |
| Comparator Agent |
Tablet Tadalafil 5mg |
Tablet Tadalafil 5mg once daily orally at bedtime for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
An International Prostatic Symptom Score (IPSS) of more than 7,
Maximum Urinary Flow Rate (Qmax) less than 15 ml/second with minimum voided volume of more than 150 ml at screening,
Willing and able to give written informed consent and comply with study procedures,
Patients agreed not to use BPH medications during the research other than the study medications.
|
|
| ExclusionCriteria |
| Details |
Known allergy or contraindications to Silodosin and Tadalafil and use of finasteride or dutasteride,
History of syncope, and orthostatic hypotension,
Bladder outlet obstruction due to cancer, calculi or stricture,
Previous Transurethral Resection of the Prostate (TURP),
Any neurological disorders affecting storage and voiding functions,
Prostatitis,
PSA greater than 4 ng/ml,
An episode of acute urinary retention within 4 weeks of study initiation,
Documented urinary tract infection,
Poorly controlled diabetes mellitus,
Poorly controlled hypertension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate improvement in IPSS score for lower urinary tract symptoms due to Benign Prostatic Hyperplasia. |
4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate improvement in IPSS QoL INDEX, improvement in Qmax, improvement in PVR, improvement in erectile function [EF] domain scores from IIEF 5 efficacy end points, and to determine safety assessment of Silodosin and Tadalafil including patient’s reporting of adverse event. |
4 weeks, 8 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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)
|
15/07/2020 |
| 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="6"
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
|
Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in middle-aged and elderly men. LUTS due to Prostatic enlargement leads to voiding symptoms and storage symptoms. LUTS is known to interfere with the activities of daily living and decrease the quality of life (QoL). The objective of medical therapy is to improve LUTS due to BPH and hence quality of life. For LUTS due to BPH, medical management with both α1-adrenoceptor blockers and phosphodiesterase type 5 inhibitors are recommended. There is limited scientific literature comparing the efficacy and safety of selective alpha blocker Silodosin and Tadalafil either as monotherapy or combination. Therefore, we will conduct an open label randomized control trial in patients with LUTS due to BPH and compare the efficacy and safety of Silodosin and Tadalafil |