Benign Prostate HyperplasiaPhase 3NCT02827578
Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia
A Phase 3 study testing Tamsulosin and Solifenacin in people with Benign Prostate Hyperplasia, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- Tamsulosin and Solifenacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Dec 2017
- 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
- Healthy male aged 45 years old or older
- Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination
- Subjects with 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 5 years
- Subjects who have acute urinary retention within 4 weeks before screening
- Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 6 months before screening
- Subjects who have hypersensitivity to investigational product or sulfa medications
- Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery,)
- Subjects who have myasthenia gravis, narrow angle glaucoma or autonomic neuropathy
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- Subjects who have cataract or glaucoma scheduled to be operated in the study duration.
- Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- 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.
moah Son contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung medical center
Seoul
Kyu Sung Lee
About this study
Official title: Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia : a Randomized, Double Blinded, Parallel Design, Active Controlled, Multi-center, Phase 3 Clinical Trial
Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- Tamsulosin, Solifenacin, Solifenacin placebo
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Tamsulosin
SolifenacinDrug
Solifenacin
Solifenacin placeboDrug
Solifenacin placebo
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin + Solifenacin | Experimental | Tamsulosin and Solifenacin Receives: Drug: Tamsulosin; Drug: Solifenacin |
| Tamsulosin + Solifenacin Placebo | Active comparator | Tamsulosin and Solifenacin placebo Receives: Drug: Tamsulosin; Drug: Solifenacin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of TUFS((Total Urgency and Frequency Score)/24h
Measured: From baseline at week 12
The change of total IPSS(International prostate symptom score)
Measured: From baseline at week 12
Secondary outcomes (9)
The change of urgency/24h
Measured: From baseline at week 4, 8 and 12
The change of voiding frequency/24h
Measured: From baseline at week 4, 8 and 12
The change of nocturnal frequency/24h
Measured: From baseline at week 4, 8 and 12
The change of urge urinary incontinence frequency/24h
Measured: From baseline at week 4, 8 and 12
The change of IPSS(International prostate symptom score)-sub score
Measured: From baseline at week 4, 8 and 12
The change of PPBC(Patient perception of bladder condition)
Measured: From baseline at week 4 and 12
The change of IPSS(International prostate symptom score) QoL(Quality of Life)
Measured: From baseline at week 4, 8 and 12
PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change)
Measured: From baseline at week 12
The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4
Measured: From baseline at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827578
- Sponsor's protocol ID
- ID-TASO-301
- Status last verified
- Apr 2016
- First submitted
- 6 Jul 2016
- Last updated
- 13 Jul 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 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia : a Randomized, Double Blinded, Parallel Design, Active Controlled, Multi-center, Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT02827578
- Acronym / sponsor ID
- ID-TASO-301
- Conditions
- Benign Prostate Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Jul 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.
Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin + Solifenacin | Experimental | Drug: Tamsulosin, Drug: SolifenacinTamsulosin and Solifenacin |
| Tamsulosin + Solifenacin Placebo | Active comparator | Drug: Tamsulosin, Drug: Solifenacin placeboTamsulosin and Solifenacin placebo |
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)
- Healthy male aged 45 years old or older
- Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination
- Subjects with lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form
Key exclusion criteria (9 listed)
- Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years
- Subjects who have acute urinary retention within 4 weeks before screening
- Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 6 months before screening
- Subjects who have hypersensitivity to investigational product or sulfa medications
- Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery,)
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 |
|---|---|---|
| TamsulosinTamsulosin | Drug | Tamsulosin + Solifenacin, Tamsulosin + Solifenacin Placebo |
| SolifenacinSolifenacin | Drug | Tamsulosin + Solifenacin |
| Solifenacin placeboSolifenacin placebo | Drug | Tamsulosin + Solifenacin Placebo |
Primary outcome
The change of TUFS((Total Urgency and Frequency Score)/24h
Time frame: From baseline at week 12
The change of total IPSS(International prostate symptom score)
Time frame: From baseline at week 12
9 secondary outcomes
The change of urgency/24h
Time frame: From baseline at week 4, 8 and 12
The change of voiding frequency/24h
Time frame: From baseline at week 4, 8 and 12
The change of nocturnal frequency/24h
Time frame: From baseline at week 4, 8 and 12
The change of urge urinary incontinence frequency/24h
Time frame: From baseline at week 4, 8 and 12
The change of IPSS(International prostate symptom score)-sub score
Time frame: From baseline at week 4, 8 and 12
The change of PPBC(Patient perception of bladder condition)
Time frame: From baseline at week 4 and 12
The change of IPSS(International prostate symptom score) QoL(Quality of Life)
Time frame: From baseline at week 4, 8 and 12
PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change)
Time frame: From baseline at week 12
The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4
Time frame: From baseline at week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
moah Son contact
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 and Solifenacin in people with Benign Prostate Hyperplasia, run by IlDong 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 9 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: status not confirmed, as of the sponsor's last update on 13 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact moah Son (sonmoah@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of TUFS((Total Urgency and Frequency Score)/24h (time frame: From baseline at week 12). 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 13 Jul 2016.