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

November 17, 2015 updated by: Astellas Pharma Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Harnalidge® OCAS®
Drug: Tamsulosin OCAS
oral
Other Names:
  • Harnalidge® OCAS®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes from baseline in total scores of International Prostate Symptom Score (IPSS)
Time Frame: baseline, 4-week, 8-week, 12 week
baseline, 4-week, 8-week, 12 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in IPSS subscore
Time Frame: baseline, 4-week, 8-week, 12 week
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)
Time Frame: baseline, 4-week, 8-week, 12 week
baseline, 4-week, 8-week, 12 week
Changes from baseline in Uroflowmetry parameters
Time Frame: baseline, 4-week, 8-week, 12 week
Uroflowmetry parameters include Qmax, Qave, and voided volume
baseline, 4-week, 8-week, 12 week
Changes from baseline in Visual Analogue Scale (VAS)
Time Frame: baseline, 4-week, 8-week, 12 week
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
Time Frame: Up to 12 week
Up to 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Astellas Pharma Taiwan, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HAURO-1201-TW

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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