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

Prostatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701311
• Other study ID #: 2007-135
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2008
• Last updated: September 25, 2014
• Start date: June 2008
• Est. completion date: March 2011

Study information

• Verified date: September 2014
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• CC-10004
CC-10004 20 mg per day

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth Peters, MD	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No