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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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Tamsulosin OCAS
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) focused on measuring tamsulosin,, benign prostatic hyperplasia,, α1-adrenoceptor antagonists

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Harnalidge® OCAS®

Arm Description

Outcomes

Primary Outcome Measures

Changes from baseline in total scores of International Prostate Symptom Score (IPSS)

Secondary Outcome Measures

Changes from baseline in IPSS subscore
IPSS subscores include storage subscores, voiding subscores and nocturia
Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL)
Changes from baseline in Uroflowmetry parameters
Uroflowmetry parameters include Qmax, Qave, and voided volume
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
Safety assessed by the adverse events, physical examination, vital signs and post void residual volume

Full Information

First Posted
June 25, 2014
Last Updated
November 17, 2015
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02180789
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
Keywords
tamsulosin,, benign prostatic hyperplasia,, α1-adrenoceptor antagonists

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Harnalidge® OCAS®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tamsulosin OCAS
Other Intervention Name(s)
Harnalidge® OCAS®
Intervention Description
oral
Primary Outcome Measure Information:
Title
Changes from baseline in total scores of International Prostate Symptom Score (IPSS)
Time Frame
baseline, 4-week, 8-week, 12 week
Secondary Outcome Measure Information:
Title
Changes from baseline in IPSS subscore
Description
IPSS subscores include storage subscores, voiding subscores and nocturia
Time Frame
baseline, 4-week, 8-week, 12 week
Title
Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL)
Time Frame
baseline, 4-week, 8-week, 12 week
Title
Changes from baseline in Uroflowmetry parameters
Description
Uroflowmetry parameters include Qmax, Qave, and voided volume
Time Frame
baseline, 4-week, 8-week, 12 week
Title
Changes from baseline in Visual Analogue Scale (VAS)
Description
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
Time Frame
baseline, 4-week, 8-week, 12 week
Title
Safety assessed by the adverse events, physical examination, vital signs and post void residual volume
Time Frame
Up to 12 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Linkou
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=HAURO-1201-TW
Description
Link to results on Astellas Clinical Study Results Web site

Learn more about this trial

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

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