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

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).

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Drug: Tamsulosin OCAS

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Linkou, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Harnalidge® OCAS®	Drug: Tamsulosin OCAS; oral; Other Names: Harnalidge® OCAS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Taiwan, Inc.

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results Web site

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 3, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: tamsulosin,; benign prostatic hyperplasia,; α1-adrenoceptor antagonists
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: HAURO-1201-TW