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

Primary Purpose

Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC-10004
Sponsored by
Kenneth Peters, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatitis focused on measuring Prostatitis, Pelvic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • William Beaumont Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Drug CC-10004

Arm Description

Study drug CC-10004 20mg taken orally twice a day.

Outcomes

Primary Outcome Measures

Global Response Assessment
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.

Secondary Outcome Measures

Full Information

First Posted
June 18, 2008
Last Updated
September 25, 2014
Sponsor
Kenneth Peters, MD
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00701311
Brief Title
An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Official Title
An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Peters, MD
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords
Prostatitis, Pelvic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Drug CC-10004
Arm Type
Experimental
Arm Description
Study drug CC-10004 20mg taken orally twice a day.
Intervention Type
Drug
Intervention Name(s)
CC-10004
Intervention Description
CC-10004 20 mg per day
Primary Outcome Measure Information:
Title
Global Response Assessment
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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