Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00648323

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate	Drug: Doxazosin mysylate GITS	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia

Study Start Date :

Nov 1, 2003

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Doxazosin mysylate GITS 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.

Arm

Intervention/Treatment

Experimental: A

Drug: Doxazosin mysylate GITS

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.

Outcome Measures

Primary Outcome Measures

Change in the maximum urinary flow rate (Qmax) from baseline [8 weeks]
Change in the International Prostate Symptom Score (IPSS) total score from baseline [8 weeks]

Secondary Outcome Measures

Change in the International Prostate Symptom Score (IPSS) total score from baseline [4 weeks]
Change in the maximum urinary flow rate (Qmax) from baseline [4 weeks]
Change in the quality of life (QoL) assessment index score from baseline [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Kaohsiung	Taiwan	813
2	Pfizer Investigational Site	Taichung	Taiwan
3	Pfizer Investigational Site	Taipei	Taiwan
4	Pfizer Investigational Site	Taoyuan	Taiwan