Back to resultsExtension Study of GI198745 to Treat Benign Prostatic Hyperplasia
Primary Purpose
Benign Prostatic Hyperplasia, Prostatic Hyperplasia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GI198745 0.05mg
GI198745 0.5mg
GI198745 2.5mg
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring GI198745, Long term extension study, BPH
Eligibility Criteria
Inclusion Criteria:
- Has been receiving the investigational product for at least 20 weeks in the preceding dose finding study and the investigator or subinvestigator has confirmed the tolerability and has judged as appropriate to participate continuously in further 28 weeks treatment.
Exclusion Criteria:
- Is withdrawn from the dose finding study.
- Has less than 75% compliance with the investigational product in the dose finding study at given the informed consent for the long-term extension study.
- Has a prostate cancer at giving informed consent for participating in the long-term extension study; or is suspected to have a prostate cancer in palpation, ultrasound imaging, biopsy, etc. at giving informed consent for participating in the long-term extension study.
- Has the post void residual volume > 250 ml at starting the long-term extension study. (as measured by suprapubic ultrasound).
- Has chronic bacterial prostatitis or chronic urinary tract infections during the dose finding study
- Has acute urinary retention in the dose finding study.
- Has a history or current evidence of drug or alcohol abuse during the dose finding study
- Has been treated with any investigational product including post-marketing clinical trials during the dose finding study.
- Has myocardial infarction, coronary arterial bypass surgery, unstable angina, arrhythmia, congestive heart failure, cerebrovascular accident during the dose finding study.
- Has any concurrent disease or complication that, in the opinion of the investigator/sub-investigator, is difficult to evaluate efficacy of GI198745 in this study and that might poses additional risk to the patient.
- Is actively trying to procreate in the study period.
- Is unsuitable for this study, in the opinion of the investigator/sub-investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GI198745
Arm Description
Outcomes
Primary Outcome Measures
adverse events, laboratory test values (hematology, serum chemistry, electrolyte, and urinalysis), prostate specific antigen (PSA), vital signs (blood pressure, pulse rate), and post-void residual volume.
Secondary Outcome Measures
prostate volume, symptom scores (IPSS), maximum urinary flow (Qmax), serum dihydrotestosterone (DHT), and testosterone
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00969072
Brief Title
Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia
Official Title
A Long-term Extension Study of GI198745 in Subjects With Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to assess the safety of GI198745 0.05mg, 0.5mg, 2.5mg once daily for 52 weeks.
Detailed Description
Upon completion of 24 weeks of GI198745 0.05 mg, 0.5 mg, 2.5 mg, or placebo therapy in study ARI20005, subjects are enrolled into an extension phase and are continued on the same therapy once daily for up to further 28 weeks, followed by up to 16 weeks of post-dosing assessments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Prostatic Hyperplasia
Keywords
GI198745, Long term extension study, BPH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GI198745
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GI198745 0.05mg
Intervention Description
GI198745 (drug) - benign prostatic hyperplasia
Intervention Type
Drug
Intervention Name(s)
GI198745 0.5mg
Intervention Description
GI198745 (drug) - benign prostatic hyperplasia
Intervention Type
Drug
Intervention Name(s)
GI198745 2.5mg
Intervention Description
GI198745 (drug) - benign prostatic hyperplasia
Primary Outcome Measure Information:
Title
adverse events, laboratory test values (hematology, serum chemistry, electrolyte, and urinalysis), prostate specific antigen (PSA), vital signs (blood pressure, pulse rate), and post-void residual volume.
Time Frame
a 28-week extension treatment in the subjects entered into the 24-week dose finding study (ARI20005: multicentre, double-blind, randomised, placebo-controlled, parallel-group)
Secondary Outcome Measure Information:
Title
prostate volume, symptom scores (IPSS), maximum urinary flow (Qmax), serum dihydrotestosterone (DHT), and testosterone
Time Frame
a 28-week extension treatment in the subjects entered into the 24-week dose finding study (ARI20005: multicentre, double-blind, randomised, placebo-controlled, parallel-group)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has been receiving the investigational product for at least 20 weeks in the preceding dose finding study and the investigator or subinvestigator has confirmed the tolerability and has judged as appropriate to participate continuously in further 28 weeks treatment.
Exclusion Criteria:
Is withdrawn from the dose finding study.
Has less than 75% compliance with the investigational product in the dose finding study at given the informed consent for the long-term extension study.
Has a prostate cancer at giving informed consent for participating in the long-term extension study; or is suspected to have a prostate cancer in palpation, ultrasound imaging, biopsy, etc. at giving informed consent for participating in the long-term extension study.
Has the post void residual volume > 250 ml at starting the long-term extension study. (as measured by suprapubic ultrasound).
Has chronic bacterial prostatitis or chronic urinary tract infections during the dose finding study
Has acute urinary retention in the dose finding study.
Has a history or current evidence of drug or alcohol abuse during the dose finding study
Has been treated with any investigational product including post-marketing clinical trials during the dose finding study.
Has myocardial infarction, coronary arterial bypass surgery, unstable angina, arrhythmia, congestive heart failure, cerebrovascular accident during the dose finding study.
Has any concurrent disease or complication that, in the opinion of the investigator/sub-investigator, is difficult to evaluate efficacy of GI198745 in this study and that might poses additional risk to the patient.
Is actively trying to procreate in the study period.
Is unsuitable for this study, in the opinion of the investigator/sub-investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia
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