Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)Phase 4NCT02180789
A Study to Evaluate the Tolerability and Efficacy of Tamsulosin 0.4mg OCAS Formulation in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2mg Conventional Formulation
A Phase 4 study testing Tamsulosin OCAS in people with Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH), run by Astellas Pharma Inc at 1 site in Taiwan.
Trial summary
This is an open-label, single-arm, prospective interventional study to assess the tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). 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 (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Tamsulosin OCAS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Jan 2015
- Phase
- Phase 4
- 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
- Diagnosed as LUTS associated with BPH
- Currently taking oral tamsulosin 0.2 mg for at least 4 weeks
- Unsatisfied with the treatment of tamsulosin 0.2 mg The definition of 'unsatisfaction' is based on patient's satisfaction. Investigator will ask patient one question "Are you satisfied with your current treatment?" prior to study enrollment
- IPSS-QOL score ≧3 points at baseline
Who cannot join
- Subjects who underwent prostatectomy during the period of one year prior to this study
- Subjects with neurogenic bladder dysfunction, bladder neck sclerosis, urethral stricture, prostatic cancer, cystolithiasis, severe vesical diverticulum, urinary tract infection
- Subjects with any other complication which may cause voiding dysfunction
- Subjects with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorders, orthostatic hypotension, or senile dementia
- Subjects clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
- Subjects who are currently participating in any other investigational drug study or who have participated in a study of an investigational drug within 3 months prior to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Prospective Interventional Study of the Tolerability and Efficacy of Oral Harnalidge® OCAS® (Tamsulosin) 0.4 mg in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2 mg
This is an open-label, single-arm, prospective interventional study to assess the tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Read the detailed description
After obtaining informed consent, subjects who meet the inclusion criteria and not violating the exclusion criteria will be enrolled to receive Harnalidge® OCAS® 0.4 mg for treatment. The interventional period for the study is three months after the first date of enrollment or until the patients are discontinued the treatment of Harnalidge® OCAS®. All subjects will be instructed to contact the site if a patient's partner becomes pregnant during or within 90 days from the discontinuation of dosing, the investigator should report the information to the sponsor as if it is an SAE.
- Being tested
- Tamsulosin OCAS
- Keywords
- tamsulosin,, benign prostatic hyperplasia,, α1-adrenoceptor antagonists
- 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 OCASDrug
Also called Harnalidge® OCAS®
oral
| Study group | Role | What they receive |
|---|---|---|
| Harnalidge® OCAS® | Experimental | Not described Receives: Drug: Tamsulosin OCAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in total scores of International Prostate Symptom Score (IPSS)
Measured: baseline, 4-week, 8-week, 12 week
Secondary outcomes (5)
Changes from baseline in IPSS subscore
IPSS subscores include storage subscores, voiding subscores and nocturia
Measured: baseline, 4-week, 8-week, 12 week
Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL)
Measured: baseline, 4-week, 8-week, 12 week
Changes from baseline in Uroflowmetry parameters
Uroflowmetry parameters include Qmax, Qave, and voided volume
Measured: baseline, 4-week, 8-week, 12 week
Changes from baseline in Visual Analogue Scale (VAS)
VAS is a vertical mark on a 10-cm line that ran from 'Not at all' to 'Yes, completely'. Patient marks on the line the point that they feel represents their perception of treatment satisfaction; 'Not at all' = 0 to 'Yes, completely' =10
Measured: baseline, 4-week, 8-week, 12 week
Safety assessed by the adverse events, physical examination, vital signs and post void residual volume
Measured: Up to 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startMar 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180789
- Sponsor's protocol ID
- HAURO-1201-TW
- Status last verified
- Nov 2015
- First submitted
- 25 Jun 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective Interventional Study of the Tolerability and Efficacy of Oral Harnalidge® OCAS® (Tamsulosin) 0.4 mg in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2 mg
- ClinicalTrials.gov ID
- NCT02180789
- Acronym / sponsor ID
- HAURO-1201-TW
- Keywords
- tamsulosin,, benign prostatic hyperplasia,, α1-adrenoceptor antagonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Jul 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.
This is an open-label, single-arm, prospective interventional study to assess the tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Detailed description
After obtaining informed consent, subjects who meet the inclusion criteria and not violating the exclusion criteria will be enrolled to receive Harnalidge® OCAS® 0.4 mg for treatment. The interventional period for the study is three months after the first date of enrollment or until the patients are discontinued the treatment of Harnalidge® OCAS®. All subjects will be instructed to contact the site if a patient's partner becomes pregnant during or within 90 days from the discontinuation of dosing, the investigator should report the information to the sponsor as if it is an SAE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harnalidge® OCAS® | Experimental | Drug: Tamsulosin OCAS |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as LUTS associated with BPH
- Currently taking oral tamsulosin 0.2 mg for at least 4 weeks
- Unsatisfied with the treatment of tamsulosin 0.2 mg The definition of 'unsatisfaction' is based on patient's satisfaction. Investigator will ask patient one question "Are you satisfied with your current treatment?" prior to study enrollment
- IPSS-QOL score ≧3 points at baseline
Key exclusion criteria (6 listed)
- Subjects who underwent prostatectomy during the period of one year prior to this study
- Subjects with neurogenic bladder dysfunction, bladder neck sclerosis, urethral stricture, prostatic cancer, cystolithiasis, severe vesical diverticulum, urinary tract infection
- Subjects with any other complication which may cause voiding dysfunction
- Subjects with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorders, orthostatic hypotension, or senile dementia
- Subjects clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
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 OCASAlso: Harnalidge® OCAS®oral | Drug | Harnalidge® OCAS® |
Primary outcome
Changes from baseline in total scores of International Prostate Symptom Score (IPSS)
Time frame: baseline, 4-week, 8-week, 12 week
5 secondary outcomes
Changes from baseline in IPSS subscore
Time frame: baseline, 4-week, 8-week, 12 week
Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL)
Time frame: baseline, 4-week, 8-week, 12 week
Changes from baseline in Uroflowmetry parameters
Time frame: baseline, 4-week, 8-week, 12 week
Changes from baseline in Visual Analogue Scale (VAS)
Time frame: baseline, 4-week, 8-week, 12 week
Safety assessed by the adverse events, physical examination, vital signs and post void residual volume
Time frame: Up to 12 week
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 18 Nov 2015.
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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.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin OCAS in people with Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH), run by Astellas Pharma Inc at 1 site in Taiwan.
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 6 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 18 Nov 2015. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes from baseline in total scores of International Prostate Symptom Score (IPSS) (time frame: baseline, 4-week, 8-week, 12 week). 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 18 Nov 2015.