CTRI

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CTRI Number

CTRI/2010/091/000526 [Registered on: 28/06/2010]

Last Modified On:

Post Graduate Thesis

Type of Trial

Type of Study

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A clinical trial to study the effects of Silodosin in patients with Benign Prostatic Hyperplasia

Scientific Title of Study

A Randomized, Open Label, Active-Controlled, and Multi-Center Phase III Clinical Trial to compare the safety and efficacy of Silodosin with that of Tamsulosin in patients of Benign Prostatic Hyperplasia

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
MSN/SILODOSIN/CT/092009A	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr. Rajesh Bajpai
Designation
Affiliation
Address	Bombay Hospital &Medical Research Centre, Mumbai Mumbai MAHARASHTRA India
Phone
Fax
Email	drrajeshbajpai@yahoo.in

Details of Contact Person
Scientific Query

Name	Dr. Rajesh Bajpai
Designation
Affiliation
Address	Bombay Hospital &Medical Research Centre, Mumbai Mumbai MAHARASHTRA India
Phone
Fax
Email	drrajeshbajpai@yahoo.in

Details of Contact Person
Public Query

Name	Dr. Rajesh Bajpai
Designation
Affiliation
Address	Bombay Hospital &Medical Research Centre, Mumbai Mumbai MAHARASHTRA India
Phone
Fax
Email	drrajeshbajpai@yahoo.in

Source of Monetary or Material Support

M/s. MSN Laboratories Ltd.

Primary Sponsor

Name	M/s. MSN Laboratories Ltd.
Address
Type of Sponsor

Details of Secondary Sponsor

Name	Address
nil

Countries of Recruitment

India

Sites of Study

No of Sites = 4
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr. Rajesh Bajpai	Bombay Hospital &Medical Research Centre, Mumbai, drrajeshbajpai@yahoo.in	,- Mumbai MAHARASHTRA	drrajeshbajpai@yahoo.in
Dr. Pramod K Sharma	Dr. S N Medical College & Hospital,Jodhpur, drpksharma49@yahoo.com	,-
Dr. Shailesh A Shah	Kidneyline Healthcare Ahmedabad, drshaileshs@yahoo.com	,-
Dr. Sanjay S Yagnik	Smruti Nursing Home, Mumbai, drssyagnik@yahoo.com	,-

Details of Ethics Committee

No of Ethics Committees= 4
Name of Committee	Approval Status
COMSARTs	Approved
COMSARTs	Approved
COMSARTs	Approved
COMSARTS	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	Benign Prostatic Hyperplasia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Silodosin capsule	8mg
Comparator Agent	Tamsulosin ER capsules	0.4 mg

Inclusion Criteria

Age From
Age To
Gender
Details	■ All patients with duly filled and signed in ICFs [Informed Consent Forms] ■ Ages: > 45 years and < 80 years ■ Genders Eligible for Study: males only ■ Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH. ■ A mean symptoms score of at least 8 [Symptoms of BPH will be assessed as per American Urological Association Symptom Index, which assesses the occurrence of seven symptoms characteristic of benign prostatic hyperplasia during the preceding week, each scored on a scale from 0 (absent) to 5 (severe)]. ■ Mean peak urinary-flow rate of no more than 15 ml per second and no less than 4 ml per second, with a minimal voided volume of 125 ml, and a mean residual volume after voiding of less than 300 ml. ■ Prostate-specific antigen [PSA] values of > 4 iu/mL ■ Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 mL/min by Cockroft and Gault formula

ExclusionCriteria

Details

■ Patients unwilling to sign on ICF ■ Patients, who have taken an -adrenergic?agonist drug, a cholinergic agonist or antagonist drug, a topical -adrenergic?antagonist drug for glaucoma, or any antihypertensive drug except a diuretic or an angiotensin-converting?enzyme inhibitor within two weeks before the lead-in period ■ Patients, who have taken an estrogen, androgen, or drug causing androgen inhibition within the preceding three months ■ Patients, an episode of unstable angina pectoris, a myocardial infarction, a transient ischemic attack, or a cerebrovascular accident in the past six months ■ Patients with insulin-dependent diabetes mellitus ■ Patients with orthostatic hypertension [defined as a difference of more than 20 mm Hg between the systolic blood pressure measured when the man was standing and that measured when he was supine, independent of concomitant changes in pulse or symptoms of postural hypotension] ■ Patients with history of syncope; a blood pressure of less than 90/70 mm Hg when the man was sitting ■ Patients with a history of carcinoma of the prostate, pelvic irradiation, or urethral stricture; surgery for benign prostatic hyperplasia or bladder-neck obstruction; current evidence of prostatic carcinoma; active urinary tract disease, cystoscopy, or biopsy of the prostate within the previous two weeks ■ Patients with prior pelvic surgery that was likely to interfere with normal bladder function ■ Patients with a history of recurrent urinary tract infections or an in infection of the urinary tract, including asymptomatic bacteriuria, within the preceding two months ■ Patients with clinically important renal or hepatic impairment (as evidenced by a serum creatinine concentration greater than 2.0 mg per deciliter [177 m/ mol per liter] or a serum alanine aminotransferase concentration more than 1.5 times the upper limit of normal); and a serum concentration of prostate-specific antigen above 10 ng per milliliter ■ Patients with a history of chronic hepatitis B or C infection, HIV infection, ■ Patients with presence or history of malignancy (within the last 2 years), or alcohol or drug abuse. ■ Patients who have received an experimental drug within 28 days of study entry will be excluded from participation, as will be patients with a history of sensitivity to silodosin, Tamsulosin or their excipients.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Primary Change in baseline score on the American Urological Association Symptom Index [Time Frame: 12 weeks ] The primary safety variable for this clinical trial is to compare the safety and tolerability of Silodosin with the placebo. The number of adverse events in each arm will be documented to evaluate the safety profile of silodosin.	12 weeks

Secondary Outcome

Outcome

TimePoints

Change in baseline urine flow rate [Time Frame: 12 weeks ] ? Change in prostate-specfic antigen [Time Frame: 12 weeks ] This includes clinical laboratory tests (hematology, biochemistry, and urinalysis), physical examinations, vital signs (body temperature, heart rate, respiratory rate, and blood pressure), and 12-lead electrocardiograms. The clinical laboratory tests (complete blood count, electrolytes, serum lipids, kidney function, pancreatic enzymes, aminotransferases, y-glutamyltransferase, and alkaline phosphatase) will be performed by a central laboratory at the time of screening and at the time of completion of the study.

12 weeks

Target Sample Size

Total Sample Size="200"
Sample Size from India=""
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)

Date Missing

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

08/05/2010

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Completed

Recruitment Status of Trial (India)

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

This study is a randomized, open label, parallel group, multi cantre trial comparing the safety and efficacy of Silodosin with that of Tamsulosin in patients of Benign Prostatic Hyperplasia in 200 patients that will be conducted in four centres in India.