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

Benign Prostatic Hyperplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303769
• Other study ID #: GL2702-301
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2014
• Last updated: February 24, 2016
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: GL Pharm Tech Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 a-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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin HCL 0.4mg
Tamsulosin HCL 0.4mg once a day
• Tamsulosin HCL 0.2mg
Tamsulosin HCL 0.2mg once a day

Locations

Country	Name	City	State
Korea, Republic of	Eulji general hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GL Pharm Tech Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint in total International Prostate Symptom Score		8 weeks	No
Secondary	Change from baseline to endpoint in total International Prostate Symptom Score		4 weeks	No
Secondary	Change from baseline to endpoint in voiding score		4 weeks, 8 weeks	No
Secondary	Change from baseline to endpoint in IPSS QoL		4 weeks, 8 weeks	No
Secondary	Change from baseline to endpoint in Qmax		4 weeks, 8 weeks	No
Secondary	Change from baseline to endpoint in PVR		4 weeks, 8 weeks	No
Secondary	Time to event/proportion of subjects with AUR		8 weeks	No
Secondary	Time to event/proportion of subjects undergoing BPH related prostatic surgery		8 weeks	No