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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Drug: Tamsulosin OCAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Harnalidge® OCAS®<br> | Drug: Tamsulosin OCAS<br>* oral<br>* Other names: Harnalidge® OCAS®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in total scores of International Prostate Symptom Score (IPSS) |  | baseline, 4-week, 8-week, 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in IPSS subscore | IPSS subscores include storage subscores, voiding subscores and nocturia | baseline, 4-week, 8-week, 12 week | 
| Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL) |  | baseline, 4-week, 8-week, 12 week | 
| Changes from baseline in Uroflowmetry parameters | Uroflowmetry parameters include Qmax, Qave, and voided volume | 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 | baseline, 4-week, 8-week, 12 week | 
| Safety assessed by the adverse events, physical examination, vital signs and post void residual volume |  | Up to 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tamsulosin,, benign prostatic hyperplasia,, α1-adrenoceptor antagonists