Study to Investigate the Efficacy and Safety of GL2702 GL... | NCT02303769

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

NCT02303769

Sponsor

GL Pharm Tech Corporation

Status

Completed

Last Update Posted

Feb 25, 2016Estimated

Enrollment

309Actual

Phase

Phase 3

Conditions

Benign Prostatic Hyperplasia

Interventions

Tamsulosin HCL 0.4mg
Tamsulosin HCL 0.2mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

May 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Nov 11, 2014

First Submission Date that Met QC Criteria

Nov 28, 2014

First Posted Date

Dec 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2016

Last Update Posted Date

Feb 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

309Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tamsulosin HCL 0.4mg	Drug	Tamsulosin HCL 0.4mg once a day	Tamsulosin HCL 0.4mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
You T Gun, MD	Eulji General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eulji general hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided