Clinical trial NCT02180789: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
Keywords: tamsulosin,
benign prostatic hyperplasia,
α1-adrenoceptor antagonists
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2014-07-03
Enrollment: 100
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in total scores of International Prostate Symptom Score (IPSS)
timeFrame: baseline, 4-week, 8-week, 12 week
Secondary outcomes:
measure: Changes from baseline in IPSS subscore
timeFrame: baseline, 4-week, 8-week, 12 week
measure: Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL)
timeFrame: baseline, 4-week, 8-week, 12 week
measure: Changes from baseline in Uroflowmetry parameters
timeFrame: baseline, 4-week, 8-week, 12 week
measure: Changes from baseline in Visual Analogue Scale (VAS)
timeFrame: baseline, 4-week, 8-week, 12 week
measure: Safety assessed by the adverse events, physical examination, vital signs and post void residual volume
timeFrame: Up to 12 week
Other outcomes:
Locations:
city: Linkou
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: