Lower Urinary Tract SymptomsPhase 3NCT02972268
Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH
A Phase 3 study testing Tamsulosin 0.2mg + Solifenacin 5mg in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- What is being tested?
- Tamsulosin 0.2mg + Solifenacin 5mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 780 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2016to 14 Aug 2018
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 45 years
- Benign Prostate Hyperplasia diagnosed by 20 mL < TRUS
- Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form
Who cannot join
- Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years
- Subjects who have acute urinary retention within 12 weeks before screening
- Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening
- Subjects who have hypersensitivity to investigational product
- Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum
- Subjects who have myasthenia gravis, narrow angle glaucoma
Show all 10Show fewer
- Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- SBP > 180 mmHg or DBP > 100 mmHg
- HbA1c > 9.0 %
- Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia
- Being tested
- Tamsulosin 0.2mg + Solifenacin 5mg, Tamsulosin 0.2mg + Placebo(Solifenacin)
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin 0.2mg + Solifenacin 5mgDrug
Tamsulosin 0.2mg + Solifenacin 5mg for 12wks
Tamsulosin 0.2mg + Placebo(Solifenacin)Drug
Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Tamsulosin 0.2mg + Solifenacin 5mg Receives: Drug: Tamsulosin 0.2mg + Solifenacin 5mg |
| Group II | Placebo comparator | Tamsulosin 0.2mg + Placebo(Solifenacin) Receives: Drug: Tamsulosin 0.2mg + Placebo(Solifenacin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of TUFS
Measured: 12 weeks from baseline
change of total IPSS
Measured: 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start1 Feb 2016
- Primary completion2 Nov 2017
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Soo Choo, MD., Ph.D, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972268
- Sponsor's protocol ID
- JLP-1207-P3
- Status last verified
- Aug 2019
- First submitted
- 21 Nov 2016
- Last updated
- 29 Aug 2019
- 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 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02972268
- Acronym / sponsor ID
- JLP-1207-P3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 23 Nov 2016 (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.
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia
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 |
|---|---|---|
| Group I | Experimental | Drug: Tamsulosin 0.2mg + Solifenacin 5mgTamsulosin 0.2mg + Solifenacin 5mg |
| Group II | Placebo comparator | Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)Tamsulosin 0.2mg + Placebo(Solifenacin) |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 45 years
- Benign Prostate Hyperplasia diagnosed by 20 mL < TRUS
- Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form
Key exclusion criteria (10 listed)
- Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years
- Subjects who have acute urinary retention within 12 weeks before screening
- Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening
- Subjects who have hypersensitivity to investigational product
- Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum
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 0.2mg + Solifenacin 5mgTamsulosin 0.2mg + Solifenacin 5mg for 12wks | Drug | Group I |
| Tamsulosin 0.2mg + Placebo(Solifenacin)Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks | Drug | Group II |
Primary outcome
change of TUFS
Time frame: 12 weeks from baseline
change of total IPSS
Time frame: 12 weeks from baseline
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 29 Aug 2019.
- 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.
Myung Soo Choo, MD., Ph.D study chair
Asan Medical Center
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 0.2mg + Solifenacin 5mg in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Jeil Pharmaceutical Co., Ltd. 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 3 inclusion and 10 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 29 Aug 2019. 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. Some participants in this study may receive a placebo. 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 of TUFS (time frame: 12 weeks from baseline). The study lists 2 primary outcomes in all. 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 29 Aug 2019.