NCT02303769

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

November 11, 2014

Last Update Submit

February 24, 2016

Conditions

Benign Prostatic Hyperplasia

Keywords

Lower Urinary Track SyndromeHarnalTamsulosin HCL 0.4mg

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to endpoint in total International Prostate Symptom Score

    8 weeks

Secondary Outcomes (7)

  • Change from baseline to endpoint in total International Prostate Symptom Score

    4 weeks

  • Change from baseline to endpoint in voiding score

    4 weeks, 8 weeks

  • Change from baseline to endpoint in IPSS QoL

    4 weeks, 8 weeks

  • Change from baseline to endpoint in Qmax

    4 weeks, 8 weeks

  • Change from baseline to endpoint in PVR

    4 weeks, 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Tamsulosin HCL 0.2mg

ACTIVE COMPARATOR

Harnal-D tablet (Tamsulosin HCL 0.2mg)

Drug: Tamsulosin HCL 0.2mg

Tamsulosin HCL 0.4mg

EXPERIMENTAL

GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)

Drug: Tamsulosin HCL 0.4mg

Interventions

Tamsulosin HCL 0.4mgDRUG

Tamsulosin HCL 0.4mg once a day

Also known as: GL2702 GLARS-NF1 Tablet
Tamsulosin HCL 0.4mg
Tamsulosin HCL 0.2mgDRUG

Tamsulosin HCL 0.2mg once a day

Also known as: Harmal D
Tamsulosin HCL 0.2mg

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prostatic cancer
  • ml \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eulji general hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • You T Gun, MD

    Eulji General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2014

First Posted

December 1, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)