Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) Clinical Trial
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
| Verified date | November 2015 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Taiwan: Department of Health |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 45 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc | Astellas Pharma Taiwan, Inc. |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes from baseline in total scores of International Prostate Symptom Score (IPSS) | baseline, 4-week, 8-week, 12 week | No | |
| Secondary | Changes from baseline in IPSS subscore | IPSS subscores include storage subscores, voiding subscores and nocturia | baseline, 4-week, 8-week, 12 week | No |
| Secondary | Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL) | baseline, 4-week, 8-week, 12 week | No | |
| Secondary | Changes from baseline in Uroflowmetry parameters | Uroflowmetry parameters include Qmax, Qave, and voided volume | baseline, 4-week, 8-week, 12 week | No |
| Secondary | 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 | No |
| Secondary | Safety assessed by the adverse events, physical examination, vital signs and post void residual volume | Up to 12 week | No |