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

NCT00701311 | Completed Phase 2 Results DMC

• 1 other identifier: 2007-135
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatitis; Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Keywords

Prostatitis; Pelvic pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Drug CC-10004

EXPERIMENTAL

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

Drug: CC-10004

Interventions

CC-10004 DRUG

CC-10004 20 mg per day

Study Drug CC-10004

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenneth Peters, MD: lead
• Celgene Corporation: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Prostatitis; Pelvic Pain

Interventions

apremilast

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The limitation of this study is that only 9 of 17 participants completed full 12 weeks of treatment and there was no placebo arm.

Results Point of Contact

• Title: Kenneth M. Peters, MD
• Organization: William Beaumont Hospital

kmpeters@beaumont.edu

248-551-0387

Study Officials

• Kenneth Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 6, 2014
• Results First Posted: May 16, 2014

Record last verified: 2014-09

Locations

US (1)