A clinical Trial in patients suffering from dysurea associated with benign prostatic hyperplasia. Clinical trial is to study efficacy, safety and tolerability of Silodosin Capsules 4 mg in comparison to Urief Capsules (reference product).

Phase 3

Completed

• Conditions: Benign prostatic hyperplasia without lower urinary tract symptoms, Dysurea associated with benign prostatic hyperplasia,

• Registration Number: CTRI/2009/091/000806
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This syudy is a comparative, single blind, parallel group, non-crossover, multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Silodosin Capsules 4 mg Vs Urief Capsules, in 200, in patients suffering from dysurea associated with benign prostatic hyperplasia. Date of enrollment is 07 December 2009.

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Out come will be measured at Day 0, 1 week, 2 week, 4 week, 6 week, 8 week and 12 week. in patients suffering from dysurea associated with benign prostatic hyperplasia. The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Blood in the urine, Dribbling after voiding, Frequent urination, Hesitant, interrupted, or weak urine stream and Recurrent, sudden, urgent need to urinate.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-12
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Male patients between 40 and 75 years of age 2.
• Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
• Patient with signs and symptoms of Dysurea Associated with benign prostatic hyperplasia, diagnosed clinically.

Exclusion Criteria

• Patients <40 & > 75 years.2. Patients with hypersensitivity to the drug.
• Concomitant illness4.
• Patients who have participated in a drug study in the past 3 months.5. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits6.
• Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.7. HIV and Australian Antigen positive subjects.8. Significant history or presence of glaucoma, cardiovascular or hematological disease.9. Any condition which are likely to hinder the compliance with the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A comparative evaluation of efficacy of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.	Day 0, 1 week,2 week, 4 week,6 week, 8 week and 12 week.
The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Blood in the urine, Dribbling after voiding, Frequent urination, Hesitant, interrupted, or weak urine stream and Recurrent, sudden, urgent need to urinate.	Day 0, 1 week,2 week, 4 week,6 week, 8 week and 12 week.

Secondary Outcome Measures

Name	Time	Method
A comparative evaluation of safety & tolerability of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.	Day 0, 1 week,

Trial Locations

Locations (3)

Dr. Kirloskar Clinic; 🇮🇳 Nashik, MAHARASHTRA, India

Gaikwad Nursing Home; 🇮🇳 Aurangabad, MAHARASHTRA, India

Trinity Multi Specialty Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Dr. Kirloskar Clinic

🇮🇳Nashik, MAHARASHTRA, India

Dr Milind Kirloskar

Principal investigator

09823033684

mskirloskar@yahoo.com