Back to resultsEvaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
Primary Purpose
Prostate
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Doxazosin mysylate GITS
Sponsored by
About this trial
This is an interventional treatment trial for Prostate focused on measuring Benign Prostate Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination [DRE] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study.
Exclusion criteria include but not limited to:
- Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months
- Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Change in the maximum urinary flow rate (Qmax) from baseline
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Secondary Outcome Measures
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Change in the maximum urinary flow rate (Qmax) from baseline
Change in the quality of life (QoL) assessment index score from baseline
Full Information
NCT ID
NCT00648323
First Posted
March 27, 2008
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00648323
Brief Title
Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
Official Title
A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate
Keywords
Benign Prostate Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Doxazosin mysylate GITS
Intervention Description
Subjects initiated on 4 mg doxazosin GITS once daily at Visit 1 for four weeks. At Visit 2 (Week 4) increased to 8 mg Doxazosin GITS if efficacy response criteria not met.
Primary Outcome Measure Information:
Title
Change in the maximum urinary flow rate (Qmax) from baseline
Time Frame
8 weeks
Title
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Time Frame
4 weeks
Title
Change in the maximum urinary flow rate (Qmax) from baseline
Time Frame
4 weeks
Title
Change in the quality of life (QoL) assessment index score from baseline
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination [DRE] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study.
Exclusion criteria include but not limited to:
Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months
Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0351063&StudyName=Evaluation%20Of%20The%20Efficacy%20And%20Safety%20Of%20The%20Doxasozin%20Gastrointestinal%20Therapeutic%20System%20%28GITS%29%20In%20Patients%20With%20Prostate%20Enlargement
Description
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Learn more about this trial
Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
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