Phase 2
Completed N=62
An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Source: ClinicalTrials.gov NCT00826514 ↗
Enrolled (actual)
62
Serious AEs
1.6%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Average Daily Pain Score at Week 6 — 5.5; 5.6; -1.4; -1.0 units on a scale
Summary
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Daily Pain Score at Week 6 |
5.5; 5.6; -1.4; -1.0 | — |
| SECONDARY Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 |
-0.8; -1.1; -1.6; -0.9; -1.5; -1.3 | — |
| SECONDARY Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 |
6.4; 6.8; -0.7; -1.2; -1.6; -0.9 | — |
| SECONDARY Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 |
25.5; 26.4; 13.0; 13.5; 4.2; 4.1 | — |
| SECONDARY Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 |
9.1; 9.4; 0.9; -0.3; 0.3; -0.6 | — |
| SECONDARY Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 |
3.0; 3.8; -0.2; -1.2; -0.6; -1.2 | — |
| SECONDARY Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 |
216.7; 208.5; -13.8; 26.8; -17.4; 12.1 | — |
| SECONDARY Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 |
3.0; 3.6; -0.2; -0.4; -0.7; -0.5 | — |
| SECONDARY Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 |
4.7; 5.1; 0.3; -0.3; -0.9; 0.2 | — |
| SECONDARY Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 |
1.9; 1.7; -0.3; -0.4; -0.5; -0.3 | — |
| SECONDARY Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 |
3.8; 3.4; 0.3; -0.9; -1.3; -0.3 | — |
| SECONDARY Number of Participants With Global Response Assessment (GRA) |
0; 1; 2; 1; 1; 0 | — |
| SECONDARY Patient Global Satisfaction Assessment |
3; 0; 5; 5; 10; 13 | — |
| SECONDARY Participant Global Preference |
5; 5; 2; 4; 2; 0 | — |
| SECONDARY Patient Willingness to Re-use Medicine |
6; 8; 6; 4; 8; 9 | — |
| SECONDARY Percentage of Participants Who Received Rescue Medication |
22; 19; 17; 17; 15; 16 | — |
| SECONDARY Amount of Rescue Medication Taken |
2681.82; 2289.47; 3117.65; 2764.71; 3366.67; 2281.25 | — |
| SECONDARY Serum and Urine Nerve Growth Factor (NGF) Levels |
31.1; 33.2; 2750; 40.2; 3909; 37.7 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
24; 21; 1; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Neurological Examination Abnormalities |
3; 1 | — |
| SECONDARY Post-void Residual (PVR) Volume |
34.1; 33.8; 19.6; 23.2; 31.4; 23.4 | — |
| SECONDARY Number of Participants With Anti-Drug Antibody (ADA) |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic prostatitis
- Male adults at least 18 years of age
- Moderate to severe chronic prostatitis, with an average pain score above a pre-defined level
- To use contraception.
Exclusion Criteria
- History of symptoms for less than 3 of the last 6 months
- History of recurrent urinary tract infections, or genito-urinary cancer
- Use of finasteride or dutasteride within 6 months.
- History of hepatitis B, C or human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT00826514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.