Benign Prostatic HyperplasiaPhase 3GL2702NCT02303769
Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS
A Phase 3 study testing Tamsulosin HCL 0.4mg and Tamsulosin HCL 0.2mg in people with Benign Prostatic Hyperplasia, run by GL Pharm Tech Corporation at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tamsulosin HCL 0.4mg and Tamsulosin HCL 0.2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 50 years old, BPH diagnosted, Adult Male Subject
- IPSS ≥ 13 point
- PSA < 4ng/mL
- 5ml/sec < Qmax ≤ 15ml/sec
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic
Read the detailed description
GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tamsulosin HCL 0.4mg, Tamsulosin HCL 0.2mg
- Keywords
- Lower Urinary Track Syndrome, Harnal, Tamsulosin HCL 0.4mg
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin HCL 0.4mgDrug
Also called GL2702 GLARS-NF1 Tablet
Tamsulosin HCL 0.4mg once a day
Tamsulosin HCL 0.2mgDrug
Also called Harmal D
Tamsulosin HCL 0.2mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin HCL 0.2mg | Active comparator | Harnal-D tablet (Tamsulosin HCL 0.2mg) Receives: Drug: Tamsulosin HCL 0.2mg |
| Tamsulosin HCL 0.4mg | Experimental | GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg) Receives: Drug: Tamsulosin HCL 0.4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in total International Prostate Symptom Score
Measured: 8 weeks
Secondary outcomes (7)
Change from baseline to endpoint in total International Prostate Symptom Score
Measured: 4 weeks
Change from baseline to endpoint in voiding score
Measured: 4 weeks, 8 weeks
Change from baseline to endpoint in IPSS QoL
Measured: 4 weeks, 8 weeks
Change from baseline to endpoint in Qmax
Measured: 4 weeks, 8 weeks
Change from baseline to endpoint in PVR
Measured: 4 weeks, 8 weeks
Time to event/proportion of subjects with AUR
Measured: 8 weeks
Time to event/proportion of subjects undergoing BPH related prostatic surgery
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- GL Pharm Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- You T Gun, MD, Principal investigator, Eulji General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303769
- Sponsor's protocol ID
- GL2702-301
- Acronym
- GL2702
- Status last verified
- Feb 2016
- First submitted
- 11 Nov 2014
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02303769
- Acronym / sponsor ID
- GL2702 / GL2702-301
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Lower Urinary Track Syndrome, Harnal, Tamsulosin HCL 0.4mg
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin HCL 0.2mg | Active comparator | Drug: Tamsulosin HCL 0.2mgHarnal-D tablet (Tamsulosin HCL 0.2mg) |
| Tamsulosin HCL 0.4mg | Experimental | Drug: Tamsulosin HCL 0.4mgGL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 50 years old, BPH diagnosted, Adult Male Subject
- IPSS ≥ 13 point
- PSA < 4ng/mL
- 5ml/sec < Qmax ≤ 15ml/sec
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosin HCL 0.4mgAlso: GL2702 GLARS-NF1 TabletTamsulosin HCL 0.4mg once a day | Drug | Tamsulosin HCL 0.4mg |
| Tamsulosin HCL 0.2mgAlso: Harmal DTamsulosin HCL 0.2mg once a day | Drug | Tamsulosin HCL 0.2mg |
Primary outcome
Change from baseline to endpoint in total International Prostate Symptom Score
Time frame: 8 weeks
7 secondary outcomes
Change from baseline to endpoint in total International Prostate Symptom Score
Time frame: 4 weeks
Change from baseline to endpoint in voiding score
Time frame: 4 weeks, 8 weeks
Change from baseline to endpoint in IPSS QoL
Time frame: 4 weeks, 8 weeks
Change from baseline to endpoint in Qmax
Time frame: 4 weeks, 8 weeks
Change from baseline to endpoint in PVR
Time frame: 4 weeks, 8 weeks
Time to event/proportion of subjects with AUR
Time frame: 8 weeks
Time to event/proportion of subjects undergoing BPH related prostatic surgery
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
You T Gun, MD principal investigator
Eulji General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin HCL 0.4mg and Tamsulosin HCL 0.2mg in people with Benign Prostatic Hyperplasia, run by GL Pharm Tech Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to endpoint in total International Prostate Symptom Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.