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Completed

NCT Number: 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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin OCAS

Drug

oral

Other names: Harnalidge® OCAS®

Primary outcomes

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

    Time frame: baseline, 4-week, 8-week, 12 week

Secondary outcomes

  1. Changes from baseline in IPSS subscore

    Time frame: baseline, 4-week, 8-week, 12 week

    IPSS subscores include storage subscores, voiding subscores and nocturia

  2. Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL)

    Time frame: baseline, 4-week, 8-week, 12 week

  3. Changes from baseline in Uroflowmetry parameters

    Time frame: baseline, 4-week, 8-week, 12 week

    Uroflowmetry parameters include Qmax, Qave, and voided volume

  4. 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

  5. Safety assessed by the adverse events, physical examination, vital signs and post void residual volume

    Time frame: Up to 12 week

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Taiwan, Inc.

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2014
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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