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Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain

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ClinicalTrials.gov Identifier: NCT00301405
Recruitment Status : Terminated (Study closed. Difficult enrollment of patients with prostatitis.)
First Posted : March 10, 2006
Last Update Posted : August 5, 2013
Sponsor:
Collaborators:
Celgene Corporation
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Tracking Information
First Submitted Date  ICMJE March 9, 2006
First Posted Date  ICMJE March 10, 2006
Last Update Posted Date August 5, 2013
Study Start Date  ICMJE March 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2013)
Decrease in pain as measured by visual analog scale
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2006)
  • 1) Decrease in pain as measured by visual analog scale using daily Visual Pain Analog Scale (appendix V)
  • 2) Improvement in symptoms as measured by CPSI (Chronic Prostatitis Symptom Index)
  • 3) Improvement in sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2006)
  • 1) Global Assessment Scale (appendix VII) to be done at baseline and at every monthly visit.
  • 2) SF-12Ò Health Survey
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain
Official Title  ICMJE Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain
Brief Summary To determine the efficacy of thalidomide for treatment of the Chronic Pelvic Pain Syndrome (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 and no definitive therapy exists.

Thalidomide is an immunomodulator (a drug that alters the immune system) and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, but not for the treatment of CP or CPPS.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Prostatitis
  • Pelvic Pain
Intervention  ICMJE Drug: Thalidomide
Open label drug
Study Arms  ICMJE Active Comparator: Thalidomide
Open Label drug
Intervention: Drug: Thalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 22, 2011)
9
Original Enrollment  ICMJE
 (submitted: March 9, 2006)
20
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male subjects aged 18 and older.
  2. Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies
  3. Subjects with a minimum score of 15 on the CPSI.
  4. Male subjects must give written informed consent.
  5. Male subjects must be willing an able to comply with the most recent version of the FDA-mandated S.T.E.P.S.â Program to include:

    • He understands and can reliably carry out all instructions.
    • He is capable of complying with the mandatory contraceptive measures that are appropriate for male patient registration, and patient surveys as described in the S.T.E.P.S.â program.
    • He has received both oral and written warning of the hazards of taking thalidomide and exposing a fetus to the drug
    • He has received both oral and written warning of the risk of possible contraception failure and of the presence of thalidomide in semen. He has been instructed that he must always use a late condom during any sexual contact with a woman of childbearing potential, even if he has undergone a successful vasectomy.
    • He acknowledges in writing his understanding of these warning and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy.
    • He agrees NOT to be a sperm or blood donor while being treated with thalidomide -

Exclusion Criteria:

  1. Subjects who are female.
  2. Subjects with a documented positive urine culture (>100,000 CFU/mL) within the past six months
  3. Subjects with duration of symptoms less than three months
  4. Subjects with active genital infections
  5. Subjects with prior urologic surgeries
  6. Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate
  7. Subjects having received prior radiation to the abdominal or pelvic area
  8. Subjects with known bladder or ureteral calculi
  9. Subjects unable to complete a voiding diary
  10. Subjects diagnosed with neuropathy
  11. Subjects with neutropenia
  12. Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state
  13. Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program
  14. Subjects with orthostatic hypotension
  15. Subjects with known malignancies in the last 2 years.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301405
Other Study ID Numbers  ICMJE 2005-149 IND #74,062
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Peters, MD, William Beaumont Hospitals
Study Sponsor  ICMJE Kenneth Peters, MD
Collaborators  ICMJE
  • Celgene Corporation
  • William Beaumont Hospitals
Investigators  ICMJE
Principal Investigator: Kenneth Peters, MD William Beaumont Hospital Hospital
PRS Account William Beaumont Hospitals
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP