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

NCT00301405 | Terminated Phase 2

• 1 other identifier: 2005-149 IND #74,062
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of thalidomide for treatment of the Chronic Pelvic Pain Syndrome (CPPS).

Conditions

Chronic Prostatitis; Pelvic Pain

Keywords

prostatitis; pelvic pain

Outcome Measures

Primary Outcomes (1)

• Decrease in pain as measured by visual analog scale

Study Arms (1)

Thalidomide

ACTIVE COMPARATOR

Open Label drug

Drug: Thalidomide

Interventions

Thalidomide DRUG

Open label drug

Thalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects aged 18 and older.
• Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies
• Subjects with a minimum score of 15 on the CPSI.
• Male subjects must give written informed consent.
• 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 -

You may not qualify if:

• Subjects who are female.
• Subjects with a documented positive urine culture (\>100,000 CFU/mL) within the past six months
• Subjects with duration of symptoms less than three months
• Subjects with active genital infections
• Subjects with prior urologic surgeries
• 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 diagnosed with neuropathy
• Subjects with neutropenia
• Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state
• Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program
• Subjects with orthostatic hypotension
• Subjects with known malignancies in the last 2 years.

Sponsors & Collaborators

• Kenneth Peters, MD: lead
• Celgene Corporation: collaborator
• Corewell Health East: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Pelvic Pain; Prostatitis

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kenneth Peters, MD

  William Beaumont Hospital Hospital

  PRINCIPAL INVESTIGATOR

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: March 9, 2006
• First Posted: March 10, 2006
• Study Start: March 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

US (1)