Trial Outcomes & Findings for Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) (NCT NCT03297398)
NCT ID: NCT03297398
Last Updated: 2021-09-16
Results Overview
The trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
16 weeks
Results posted on
2021-09-16
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo Group
Placebo: Placebo
|
OPK-88004 15 mg
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
OPK-88004 25 mg
25mg, OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
40
|
38
|
|
Overall Study
COMPLETED
|
28
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
17
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Group
Placebo: Placebo
|
OPK-88004 15 mg
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
OPK-88004 25 mg
25mg, OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
Overall Study
Sponsor's decision
|
6
|
9
|
7
|
|
Overall Study
Adverse Event
|
1
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
Baseline characteristics by cohort
| Measure |
Other
n=36 Participants
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=40 Participants
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=38 Participants
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.1 Year
STANDARD_DEVIATION 6.52 • n=5 Participants
|
64.5 Year
STANDARD_DEVIATION 5.77 • n=7 Participants
|
65.3 Year
STANDARD_DEVIATION 6.01 • n=5 Participants
|
64.6 Year
STANDARD_DEVIATION 6.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight (kilogram)
|
94.97 Kilogram
STANDARD_DEVIATION 16.937 • n=5 Participants
|
95.31 Kilogram
STANDARD_DEVIATION 19.128 • n=7 Participants
|
91.35 Kilogram
STANDARD_DEVIATION 13.564 • n=5 Participants
|
93.88 Kilogram
STANDARD_DEVIATION 16.692 • n=4 Participants
|
|
Body mass index (kilogram/meter^2)
|
30.17 Kilogram/meter^2
STANDARD_DEVIATION 5.114 • n=5 Participants
|
30.37 Kilogram/meter^2
STANDARD_DEVIATION 5.286 • n=7 Participants
|
29.36 Kilogram/meter^2
STANDARD_DEVIATION 3.442 • n=5 Participants
|
29.97 Kilogram/meter^2
STANDARD_DEVIATION 4.671 • n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThe trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo
Outcome measures
| Measure |
Other
n=36 Participants
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=38 Participants
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=35 Participants
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
Change From Baseline in PSA (%) to Week 16
|
-2.96 Percentage of serum PSA change
Standard Error 5.198
|
-1.48 Percentage of serum PSA change
Standard Error 5.569
|
-15.44 Percentage of serum PSA change
Standard Error 5.509
|
SECONDARY outcome
Timeframe: 16 weeksTo assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass
Outcome measures
| Measure |
Other
n=36 Participants
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=38 Participants
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=35 Participants
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks
Change from Baseline in Lean Body Mass (g) to Week 16
|
37.8 gram
Standard Error 439.62
|
1610.3 gram
Standard Error 489.45
|
1961.6 gram
Standard Error 522.58
|
|
Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks
Change from Baseline in Fat Mass (g) to Week 16
|
-198.2 gram
Standard Error 326.84
|
-1468.7 gram
Standard Error 373.06
|
-1491.3 gram
Standard Error 388.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksAnalysis peak flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
Outcome measures
| Measure |
Other
n=33 Participants
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=29 Participants
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=28 Participants
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Peak Flow Rate (Qmax)
|
4.26 millilitre/second
Standard Error 3.810
|
0.61 millilitre/second
Standard Error 4.072
|
1.08 millilitre/second
Standard Error 4.043
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksAnalysis mean flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
Outcome measures
| Measure |
Other
n=33 Participants
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=29 Participants
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=28 Participants
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Mean Flow Rate (Qave)
|
-0.40 millilitre/second
Standard Error 0.475
|
-0.30 millilitre/second
Standard Error 0.509
|
0.15 millilitre/second
Standard Error 0.505
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksAnalysis voided of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
Outcome measures
| Measure |
Other
n=32 Participants
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=28 Participants
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=28 Participants
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter-voided Volume (Vcomp)
|
-49.12 millilitre
Standard Error 21.294
|
-2.28 millilitre
Standard Error 22.501
|
-29.12 millilitre
Standard Error 22.714
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksAnalysis postvoid residual volume of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
Outcome measures
| Measure |
Other
n=32 Participants
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=28 Participants
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=29 Participants
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Postvoid Residual Volume (PVR)
|
-0.08 millilitre
Standard Error 10.365
|
17.63 millilitre
Standard Error 11.325
|
-15.19 millilitre
Standard Error 10.925
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksTo evaluate the effects of OPK-88004 on the symptoms of BPH as determined by International prostate symptom score (IPSS score), Total IPSS score as measured by the sum of questions 1 through 7, the IPSS Irritative Domain (sum of questions 2, 4 and 7), and the IPSS Obstructive Domain (sum of questions 1, 3, 5 and 6)IPSS QoL question (IPSS question 8). Mild (symptoms score less than or equal to 7), moderate (symptoms score range 8-19), severe (symptom score 20-35)
Outcome measures
| Measure |
Other
n=28 Participants
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=23 Participants
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=22 Participants
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
International Prostate Symptom Score- IPSS
|
14.0 Total IPSS score
Standard Deviation 7.70
|
12.8 Total IPSS score
Standard Deviation 6.21
|
14.2 Total IPSS score
Standard Deviation 7.28
|
Adverse Events
Other
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Drug Group 1
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Drug Group 2
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Other
n=36 participants at risk
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=40 participants at risk
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=38 participants at risk
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/36 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
2.6%
1/38 • 24 weeks
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/36 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
2.6%
1/38 • 24 weeks
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/36 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
2.6%
1/38 • 24 weeks
|
Other adverse events
| Measure |
Other
n=36 participants at risk
Placebo Group
Placebo: Placebo
|
Drug Group 1
n=40 participants at risk
15mg, OPK-88004
Group-1 (15mg, OPK-88004): 15mg, OPK-88004
|
Drug Group 2
n=38 participants at risk
25,mg OPK-88004
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
5.3%
2/38 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
5.3%
2/38 • 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36 • 24 weeks
|
5.0%
2/40 • 24 weeks
|
7.9%
3/38 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
1/36 • 24 weeks
|
5.0%
2/40 • 24 weeks
|
2.6%
1/38 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/36 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
5.3%
2/38 • 24 weeks
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/36 • 24 weeks
|
17.5%
7/40 • 24 weeks
|
13.2%
5/38 • 24 weeks
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/36 • 24 weeks
|
7.5%
3/40 • 24 weeks
|
7.9%
3/38 • 24 weeks
|
|
Investigations
Transaminases increased
|
2.8%
1/36 • 24 weeks
|
5.0%
2/40 • 24 weeks
|
7.9%
3/38 • 24 weeks
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/36 • 24 weeks
|
2.5%
1/40 • 24 weeks
|
10.5%
4/38 • 24 weeks
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/36 • 24 weeks
|
7.5%
3/40 • 24 weeks
|
5.3%
2/38 • 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/36 • 24 weeks
|
7.5%
3/40 • 24 weeks
|
2.6%
1/38 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/36 • 24 weeks
|
7.5%
3/40 • 24 weeks
|
2.6%
1/38 • 24 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/36 • 24 weeks
|
5.0%
2/40 • 24 weeks
|
5.3%
2/38 • 24 weeks
|
|
Investigations
Blood testosterone free decreased
|
0.00%
0/36 • 24 weeks
|
2.5%
1/40 • 24 weeks
|
7.9%
3/38 • 24 weeks
|
|
Investigations
Sperm concentration decreased
|
0.00%
0/36 • 24 weeks
|
2.5%
1/40 • 24 weeks
|
7.9%
3/38 • 24 weeks
|
|
Investigations
Apolipoprotein B increased
|
0.00%
0/36 • 24 weeks
|
7.5%
3/40 • 24 weeks
|
0.00%
0/38 • 24 weeks
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/36 • 24 weeks
|
5.0%
2/40 • 24 weeks
|
0.00%
0/38 • 24 weeks
|
|
Investigations
Blood creatine increased
|
0.00%
0/36 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
5.3%
2/38 • 24 weeks
|
|
Investigations
Liver function test increased
|
0.00%
0/36 • 24 weeks
|
5.0%
2/40 • 24 weeks
|
0.00%
0/38 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/36 • 24 weeks
|
7.5%
3/40 • 24 weeks
|
5.3%
2/38 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/36 • 24 weeks
|
7.5%
3/40 • 24 weeks
|
2.6%
1/38 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/36 • 24 weeks
|
5.0%
2/40 • 24 weeks
|
2.6%
1/38 • 24 weeks
|
|
Nervous system disorders
Headache
|
2.8%
1/36 • 24 weeks
|
2.5%
1/40 • 24 weeks
|
5.3%
2/38 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The obligations of non-disclosure and non-use set forth in the confidentiality is 10 years after expiration of the agreement
- Publication restrictions are in place
Restriction type: OTHER