Trial Outcomes & Findings for Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects (NCT NCT00368979)
NCT ID: NCT00368979
Last Updated: 2018-09-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
378 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
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 Study
STARTED
|
185
|
193
|
|
Overall Study
COMPLETED
|
160
|
163
|
|
Overall Study
NOT COMPLETED
|
25
|
30
|
Reasons for withdrawal
| Measure |
Placebo
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
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 Study
Adverse Event
|
9
|
16
|
|
Overall Study
Lack of Efficacy
|
5
|
3
|
|
Overall Study
Other
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
9
|
Baseline Characteristics
Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=181 Participants
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
n=184 Participants
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
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 6.76 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 6.07 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 6.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese
|
181 participants
n=5 Participants
|
184 participants
n=7 Participants
|
365 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=181 Participants
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
n=184 Participants
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.
|
|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52
|
-3.6 score on a scale
Standard Deviation 5.72
|
-5.5 score on a scale
Standard Deviation 5.94
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=180 Participants
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
n=183 Participants
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.
|
|---|---|---|
|
Percent Change From Baseline in Prostate Volume at Week 52
|
-8.9 cubic centimeters (cc)
Standard Deviation 18.76
|
-31.5 cubic centimeters (cc)
Standard Deviation 16.85
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.
Outcome measures
| Measure |
Placebo
n=181 Participants
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
n=184 Participants
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.
|
|---|---|---|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=2 Points
|
113 participants
|
139 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=3 Points
|
102 participants
|
128 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=4 Points
|
82 participants
|
115 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=5 Points
|
75 participants
|
94 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=6 Points
|
62 participants
|
82 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=20%
|
99 participants
|
122 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=25%
|
84 participants
|
114 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=30%
|
71 participants
|
106 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=40%
|
54 participants
|
86 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=50%
|
39 participants
|
67 participants
|
|
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement >=75%
|
7 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.
Outcome measures
| Measure |
Placebo
n=181 Participants
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
n=184 Participants
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.
|
|---|---|---|
|
Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52
|
0.6 milliliters per second (mL/sec)
Standard Deviation 3.82
|
2.2 milliliters per second (mL/sec)
Standard Deviation 4.89
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec
Outcome measures
| Measure |
Placebo
n=179 Participants
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
n=183 Participants
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.
|
|---|---|---|
|
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement >=2 mL/sec
|
56 participants
|
86 participants
|
|
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement >=1 mL/sec
|
79 participants
|
103 participants
|
|
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement >=2.5 mL/sec
|
45 participants
|
73 participants
|
|
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement >=3 mL/sec
|
44 participants
|
70 participants
|
|
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement >=4 mL/sec
|
29 participants
|
53 participants
|
|
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement >=5 mL/sec
|
22 participants
|
44 participants
|
|
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement >=10 mL/sec
|
4 participants
|
11 participants
|
|
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement >=30%
|
41 participants
|
63 participants
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 116 other events
Deaths: 0 deaths
Dutasteride
Serious events: 20 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=184 participants at risk
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
n=193 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
1.6%
3/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.1%
2/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.00%
0/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.54%
1/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.00%
0/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.54%
1/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.54%
1/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.00%
0/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymph node cancer metastatic
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Nervous system disorders
Cerebral infarction
|
1.1%
2/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.54%
1/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.00%
0/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.54%
1/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.00%
0/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Vascular disorders
Microscopic polyangiitis
|
0.54%
1/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.00%
0/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
0.52%
1/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
Other adverse events
| Measure |
Placebo
n=184 participants at risk
Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
|
Dutasteride
n=193 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
42.4%
78/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
41.5%
80/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
16/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
9.8%
19/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.6%
14/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
9.8%
19/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
14/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
6.2%
12/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Constipation
|
6.5%
12/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
6.7%
13/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.3%
8/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
7.3%
14/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Nervous system disorders
Headache
|
6.0%
11/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
4.1%
8/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
6/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
5.2%
10/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
4/184
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
5.2%
10/193
Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.
|
Additional Information
GSK Response center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER