An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00701311
First received: June 18, 2008
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Prostatitis
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Drug: CC-10004
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Global Response Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.

    The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale.



Enrollment: 21
Study Start Date: June 2008
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Drug CC-10004
Study drug CC-10004 20mg taken orally twice a day.
Drug: CC-10004
CC-10004 20 mg per day
Other Name: CC-10004

Detailed Description:

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. Unlike bacterial prostatitis, where a clear infecting organism can be determined, CP/CPPS is not always treated with antibiotics.

Due to the significant inflammatory nature of CP/CPPS, most prior therapies have focused on targeting the inflammation. CC-10004 in several studies has shown to be an inhibitor of inflammatory mediators, and may decrease the pain experienced from CP/CPPS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 < 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701311

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
Celgene Corporation
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00701311     History of Changes
Other Study ID Numbers: 2007-135
Study First Received: June 18, 2008
Results First Received: December 19, 2013
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by William Beaumont Hospitals:
Prostatitis
Pelvic pain

Additional relevant MeSH terms:
Pelvic Pain
Prostatitis
Chronic Disease
Somatoform Disorders
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes
Mental Disorders
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 18, 2014