An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
CompletedPhase 2NCT00701311
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
- Interventions
- Drug: CC-10004
- Sponsor
- Kenneth Peters, MD
- Collaborators
- Celgene Corporation
- Organization
- Corewell Health East
- Start date
- 2008-06
- Primary completion
- 2011-01
- Sex
- Male
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 \< 20,000/mL (\< 20 X 109/L) * Platelets ≥ 100,000 /mL (≥ 100 X 109/L) * Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L) * Total bilirubin £ 2.0 mg/dL * Aspartate transaminase (AST) serum glutamic oxaloacetic transaminase (SGOT), and alanine transaminase (ALT) serum glutamate pyruvic transaminase,(SGPT), \< 1.5x upper limit of normal (ULN) * Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with female capable of becoming pregnant while on study medication and for 28 days after taking the last dose of study medication Exclusion Criteria: * Subjects who are female. * Subjects with a documented positive urine culture within the past three months * Subjects with duration of symptoms less than three months * Subjects with genital infections within the past three months * Subjects with clinical epididymitis within the past three months * Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate * Subjects having received prior radiation to the abdominal or pelvic area * Subjects with known bladder or ureteral calculi * Subjects unable to complete a voiding diary * Subjects with neutropenia (ANC \< 750/ mm3) * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study * History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred \> 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…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00701311