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Completed

NCT Number: NCT02303769

Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - 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

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Eulji general hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin HCL 0.4mg

Drug

Tamsulosin HCL 0.4mg once a day

Other names: GL2702 GLARS-NF1 Tablet

Tamsulosin HCL 0.2mg

Drug

Tamsulosin HCL 0.2mg once a day

Other names: Harmal D

Primary outcomes

  1. Change from baseline to endpoint in total International Prostate Symptom Score

    Time frame: 8 weeks

Secondary outcomes

  1. Change from baseline to endpoint in total International Prostate Symptom Score

    Time frame: 4 weeks

  2. Change from baseline to endpoint in voiding score

    Time frame: 4 weeks, 8 weeks

  3. Change from baseline to endpoint in IPSS QoL

    Time frame: 4 weeks, 8 weeks

  4. Change from baseline to endpoint in Qmax

    Time frame: 4 weeks, 8 weeks

  5. Change from baseline to endpoint in PVR

    Time frame: 4 weeks, 8 weeks

  6. Time to event/proportion of subjects with AUR

    Time frame: 8 weeks

  7. Time to event/proportion of subjects undergoing BPH related prostatic surgery

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

GL Pharm Tech Corporation

Industry

Registry information

Official study 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

Acronym: GL2702

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2014
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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