Back to resultsStudy to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS (GL2702)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tamsulosin HCL 0.4mg
Tamsulosin HCL 0.2mg
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Lower Urinary Track Syndrome, Harnal, Tamsulosin HCL 0.4mg
Eligibility Criteria
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
Sites / Locations
- Eulji general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tamsulosin HCL 0.2mg
Tamsulosin HCL 0.4mg
Arm Description
Harnal-D tablet (Tamsulosin HCL 0.2mg)
GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)
Outcomes
Primary Outcome Measures
Change from baseline to endpoint in total International Prostate Symptom Score
Secondary Outcome Measures
Change from baseline to endpoint in total International Prostate Symptom Score
Change from baseline to endpoint in voiding score
Change from baseline to endpoint in IPSS QoL
Change from baseline to endpoint in Qmax
Change from baseline to endpoint in PVR
Time to event/proportion of subjects with AUR
Time to event/proportion of subjects undergoing BPH related prostatic surgery
Full Information
NCT ID
NCT02303769
First Posted
November 11, 2014
Last Updated
February 24, 2016
Sponsor
GL Pharm Tech Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02303769
Brief Title
Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS
Acronym
GL2702
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GL Pharm Tech Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Lower Urinary Track Syndrome, Harnal, Tamsulosin HCL 0.4mg
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin HCL 0.2mg
Arm Type
Active Comparator
Arm Description
Harnal-D tablet (Tamsulosin HCL 0.2mg)
Arm Title
Tamsulosin HCL 0.4mg
Arm Type
Experimental
Arm Description
GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)
Intervention Type
Drug
Intervention Name(s)
Tamsulosin HCL 0.4mg
Other Intervention Name(s)
GL2702 GLARS-NF1 Tablet
Intervention Description
Tamsulosin HCL 0.4mg once a day
Intervention Type
Drug
Intervention Name(s)
Tamsulosin HCL 0.2mg
Other Intervention Name(s)
Harmal D
Intervention Description
Tamsulosin HCL 0.2mg once a day
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in total International Prostate Symptom Score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to endpoint in total International Prostate Symptom Score
Time Frame
4 weeks
Title
Change from baseline to endpoint in voiding score
Time Frame
4 weeks, 8 weeks
Title
Change from baseline to endpoint in IPSS QoL
Time Frame
4 weeks, 8 weeks
Title
Change from baseline to endpoint in Qmax
Time Frame
4 weeks, 8 weeks
Title
Change from baseline to endpoint in PVR
Time Frame
4 weeks, 8 weeks
Title
Time to event/proportion of subjects with AUR
Time Frame
8 weeks
Title
Time to event/proportion of subjects undergoing BPH related prostatic surgery
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You T Gun, MD
Organizational Affiliation
Eulji General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eulji general hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS
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