Phase 2
N=17
An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Prostatitis · Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00701311 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Global Response Assessment — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CC-10004 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Kenneth Peters, MD
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Response Assessment |
2 | — |
Summary
Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and decreased quality of life. Little is known about the cause of CP/CPPS. Likewise, no definitive therapy exists for CP/CPPS. We plan to study the use of CC-10004 in men with CP/CPPS.
Eligibility Criteria
Inclusion Criteria
- Must be male aged ≥ 18 years at time of consent
- Must understand and voluntarily sign an informed consent form
- Male subjects with at least 3 months of symptoms of CP/CPPS (pain in the pelvic area, penis, scrotum, or perineum) who are refractory to other therapies (e.g. NSAIDS)
- Must be able to adhere to the study visit schedule and other protocol requirements
- Diagnosis of Chronic Prostatitis with a Chronic Prostatitis Symptom Index of at least 15/24
- Must meet the following laboratory criteria:
- Hemoglobin > 9 g/dL
- Hematocrit ≥ 27%
- White blood cell (WBC) count ≥ 3000 /mL (≥ 3.0 X 109/L) and 3 years prior to entry must have been effectively treated.
- Positive Tuberculin skin test (Mantoux test)
- Clinically significant abnormality on the chest x-ray (CXR) at screening
- Any clinically significant abnormality on 12-lead ECG at screening
- Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
- History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
- Subjects currently taking chemotherapeutic agents
- Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening.
- Subjects with known history of significant disease as determined by the PI
Data sourced from ClinicalTrials.gov (NCT00701311). 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.