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Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
Phase 2 trial testing Group-1 (15mg, OPK-88004) in Benign Prostatic Hyperplasia in 114 participants. Terminated before completion.
| Lead sponsor | OPKO Health, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 114 |
| Start date | 21 February 2018 |
| Primary completion | 18 April 2019 |
| Estimated completion | 10 June 2019 |
| Sites | 15 locations across United States |
OPKO Health, Inc. — full company profile →
45 and older, male only, with Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Other | -2.96 | ± 5.198 |
| Drug Group 1 | -1.48 | ± 5.569 |
| Drug Group 2 | -15.44 | ± 5.509 |
To assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass
| Group | Value | 95% CI |
|---|---|---|
| Other | 37.8 | ± 439.62 |
| Drug Group 1 | 1610.3 | ± 489.45 |
| Drug Group 2 | 1961.6 | ± 522.58 |
| Group | Value | 95% CI |
|---|---|---|
| Other | -198.2 | ± 326.84 |
| Drug Group 1 | -1468.7 | ± 373.06 |
| Drug Group 2 | -1491.3 | ± 388.98 |
Analysis peak flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
| Group | Value | 95% CI |
|---|---|---|
| Other | 4.26 | ± 3.810 |
| Drug Group 1 | 0.61 | ± 4.072 |
| Drug Group 2 | 1.08 | ± 4.043 |
Analysis mean flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
| Group | Value | 95% CI |
|---|---|---|
| Other | -0.40 | ± 0.475 |
| Drug Group 1 | -0.30 | ± 0.509 |
| Drug Group 2 | 0.15 | ± 0.505 |
Analysis voided of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
| Group | Value | 95% CI |
|---|---|---|
| Other | -49.12 | ± 21.294 |
| Drug Group 1 | -2.28 | ± 22.501 |
| Drug Group 2 | -29.12 | ± 22.714 |
Analysis postvoid residual volume of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
| Group | Value | 95% CI |
|---|---|---|
| Other | -0.08 | ± 10.365 |
| Drug Group 1 | 17.63 | ± 11.325 |
| Drug Group 2 | -15.19 | ± 10.925 |
To 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)
| Group | Value | 95% CI |
|---|---|---|
| Other | 14.0 | ± 7.70 |
| Drug Group 1 | 12.8 | ± 6.21 |
| Drug Group 2 | 14.2 | ± 7.28 |
Time frame: 24 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Other | Drug Group 1 | Drug Group 2 |
|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | — | — | — |
| Bile duct obstruction | Hepatobiliary disorders | — | — | — |
| Cholangitis | Hepatobiliary disorders | — | — | — |
| Reaction | System | Other | Drug Group 1 | Drug Group 2 |
|---|---|---|---|---|
| Blood testosterone decreased | Investigations | — | — | — |
| High density lipoprotein decreased | Investigations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Low density lipoprotein increased | Investigations | — | — | — |
| Transaminases increased | Investigations | — | — | — |
| Prostatic specific antigen increased | Investigations | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Blood testosterone free decreased | Investigations | — | — | — |
| Sperm concentration decreased | Investigations | — | — | — |
| Apolipoprotein B increased | Investigations | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — | — |
| Blood cholesterol increased | Investigations | — | — | — |
| Blood creatine increased | Investigations | — | — | — |
| Liver function test increased | Investigations | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
Most-reported serious reactions: Coronary artery disease, Bile duct obstruction, Cholangitis.
Data from ClinicalTrials.gov NCT03297398 adverse events section.
This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia (BPH).
2 peer-reviewed publications reference this trial (live from Europe PMC):
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