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Trial record 48 of 118 for:    DUTASTERIDE

Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00368979
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : April 2, 2009
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Prostatic Hyperplasia
Interventions Drug: Dutasteride
Drug: Placebo
Enrollment 378
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments. Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Period Title: Overall Study
Started 185 193
Completed 160 163
Not Completed 25 30
Reason Not Completed
Adverse Event             9             16
Lack of Efficacy             5             3
Other             3             1
Lost to Follow-up             1             0
Protocol Violation             2             1
Withdrawal by Subject             5             9
Arm/Group Title Placebo Dutasteride Total
Hide Arm/Group Description Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments. Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments. Total of all reporting groups
Overall Number of Baseline Participants 181 184 365
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants 184 participants 365 participants
66.9  (6.76) 68.0  (6.07) 67.4  (6.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 184 participants 365 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
181
 100.0%
184
 100.0%
365
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian-Japanese Number Analyzed 181 participants 184 participants 365 participants
181 184 365
1.Primary Outcome
Title Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52
Hide Description The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Overall Number of Participants Analyzed 181 184
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.6  (5.72) -5.5  (5.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.6
Confidence Interval 95%
-2.7 to -0.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in Prostate Volume at Week 52
Hide Description Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Overall Number of Participants Analyzed 180 183
Mean (Standard Deviation)
Unit of Measure: cubic centimeters (cc)
-8.9  (18.76) -31.5  (16.85)
3.Secondary Outcome
Title Number of Participants With IPSS Improvement From Baseline at Week 52
Hide Description Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Overall Number of Participants Analyzed 181 184
Measure Type: Number
Unit of Measure: participants
Improvement >=2 Points 113 139
Improvement >=3 Points 102 128
Improvement >=4 Points 82 115
Improvement >=5 Points 75 94
Improvement >=6 Points 62 82
Improvement >=20% 99 122
Improvement >=25% 84 114
Improvement >=30% 71 106
Improvement >=40% 54 86
Improvement >=50% 39 67
Improvement >=75% 7 17
4.Secondary Outcome
Title Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52
Hide Description Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Overall Number of Participants Analyzed 181 184
Mean (Standard Deviation)
Unit of Measure: milliliters per second (mL/sec)
0.6  (3.82) 2.2  (4.89)
5.Secondary Outcome
Title Number of Participants With Qmax Improvement From Baseline at Week 52
Hide Description Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Overall Number of Participants Analyzed 179 183
Measure Type: Number
Unit of Measure: participants
Improvement >=1 mL/sec 79 103
Improvement >=2 mL/sec 56 86
Improvement >=2.5 mL/sec 45 73
Improvement >=3 mL/sec 44 70
Improvement >=4 mL/sec 29 53
Improvement >=5 mL/sec 22 44
Improvement >=10 mL/sec 4 11
Improvement >=30% 41 63
Time Frame [Not Specified]
Adverse Event Reporting Description Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
 
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments. Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
All-Cause Mortality
Placebo Dutasteride
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Dutasteride
Affected / at Risk (%) Affected / at Risk (%)
Total   8/184 (4.35%)   20/193 (10.36%) 
Cardiac disorders     
Acute myocardial infarction  1  0/184 (0.00%)  1/193 (0.52%) 
Coronary artery stenosis  1  1/184 (0.54%)  0/193 (0.00%) 
Eye disorders     
Macular degeneration  1  0/184 (0.00%)  1/193 (0.52%) 
Gastrointestinal disorders     
Colonic polyp  1  0/184 (0.00%)  3/193 (1.55%) 
Inguinal hernia  1  2/184 (1.09%)  0/193 (0.00%) 
Enterocolitis  1  0/184 (0.00%)  1/193 (0.52%) 
Haemorrhoids  1  1/184 (0.54%)  0/193 (0.00%) 
Intestinal obstruction  1  0/184 (0.00%)  1/193 (0.52%) 
Hepatobiliary disorders     
Cholangitis  1  0/184 (0.00%)  1/193 (0.52%) 
Infections and infestations     
Pneumonia  1  0/184 (0.00%)  1/193 (0.52%) 
Urinary tract infection  1  0/184 (0.00%)  1/193 (0.52%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/184 (0.00%)  1/193 (0.52%) 
Lumbar spinal stenosis  1  1/184 (0.54%)  0/193 (0.00%) 
Synovitis  1  0/184 (0.00%)  1/193 (0.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  1  1/184 (0.54%)  1/193 (0.52%) 
Bladder cancer  1  1/184 (0.54%)  0/193 (0.00%) 
Lymph node cancer metastatic  1  0/184 (0.00%)  1/193 (0.52%) 
Meningioma  1  0/184 (0.00%)  1/193 (0.52%) 
Pancreatic carcinoma  1  0/184 (0.00%)  1/193 (0.52%) 
Nervous system disorders     
Cerebral infarction  1  2/184 (1.09%)  1/193 (0.52%) 
Dementia Alzheimer's type  1  0/184 (0.00%)  1/193 (0.52%) 
Thrombotic stroke  1  0/184 (0.00%)  1/193 (0.52%) 
Vascular disorders     
Aortic dissection  1  0/184 (0.00%)  1/193 (0.52%) 
Microscopic polyangiitis  1  1/184 (0.54%)  0/193 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dutasteride
Affected / at Risk (%) Affected / at Risk (%)
Total   116/184 (63.04%)   124/193 (64.25%) 
Gastrointestinal disorders     
Diarrhoea  1  16/184 (8.70%)  19/193 (9.84%) 
Constipation  1  12/184 (6.52%)  13/193 (6.74%) 
Gastritis  1  4/184 (2.17%)  10/193 (5.18%) 
Infections and infestations     
Nasopharyngitis  1  78/184 (42.39%)  80/193 (41.45%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  14/184 (7.61%)  12/193 (6.22%) 
Arthralgia  1  6/184 (3.26%)  10/193 (5.18%) 
Nervous system disorders     
Headache  1  11/184 (5.98%)  8/193 (4.15%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract inflammation  1  14/184 (7.61%)  19/193 (9.84%) 
Skin and subcutaneous tissue disorders     
Eczema  1  8/184 (4.35%)  14/193 (7.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00368979    
Other Study ID Numbers: ARI105326
First Submitted: August 24, 2006
First Posted: August 29, 2006
Results First Submitted: December 5, 2008
Results First Posted: April 2, 2009
Last Update Posted: September 26, 2018