Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS (GL2702)

February 24, 2016 updated by: GL Pharm Tech Corporation

A Multicenter, Randomized, Double -Blind, Parallel, Comparative, Phase III Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1 Tablet in BPH Patients With LUTS

Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Over 50 years old, BPH diagnosted, Adult Male Subject
  • IPSS ≥ 13 point
  • PSA < 4ng/mL
  • 5ml/sec < Qmax ≤ 15ml/sec

Exclusion Criteria:

  • Prostatic cancer
  • 250ml < PVR
  • ALT or AST > 2 times (Upper Normal Range)
  • Total Bilirubin > 1.5 times (Upper Normal Range)
  • Treated with α-adrenalin receptor blocker within 2weeks before screening
  • Treated with 5Alpha-Reductase Inhibitor within 6 months before screening
  • Treated with phytotherapy within 2weeks before screening
  • Treated with Anabolic Steroid within 6 months before screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tamsulosin HCL 0.2mg
Harnal-D tablet (Tamsulosin HCL 0.2mg)
Drug: Tamsulosin HCL 0.2mg
Tamsulosin HCL 0.2mg once a day
Other Names:
  • Harmal D
Experimental: Tamsulosin HCL 0.4mg
GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)
Drug: Tamsulosin HCL 0.4mg
Tamsulosin HCL 0.4mg once a day
Other Names:
  • GL2702 GLARS-NF1 Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to endpoint in total International Prostate Symptom Score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to endpoint in total International Prostate Symptom Score
Time Frame: 4 weeks
4 weeks
Change from baseline to endpoint in voiding score
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Change from baseline to endpoint in IPSS QoL
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Change from baseline to endpoint in Qmax
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Change from baseline to endpoint in PVR
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Time to event/proportion of subjects with AUR
Time Frame: 8 weeks
8 weeks
Time to event/proportion of subjects undergoing BPH related prostatic surgery
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GL Pharm Tech Corporation

Investigators

  • Principal Investigator: You T Gun, MD, Eulji General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 28, 2014

First Posted (Estimate)

December 1, 2014

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL2702-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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