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Therapeutic Areas: Nephrology/Urology
Disease Category: Prostate Disorders

Trial Information

Chronic Prostatitis Clinical Trail

We are conducting a study of males or female that are 18 years or older with Chronic Prostatitis.

Patient Inclusion Criteria:

• Must be 18 years of age
• Must have clinical diagnosis of prostatitis
• Must be under 350lbs

Patient Exclusion Criteria:

• Have symptoms of chronic prostatitis for less than 3 months of the last 6 months prior to screening
• Have a any history of: Genitourinary tuberculosis, bladder cancer, urethral cancer, prostate cancer; microbiologically-proven UTI- defined as 2 or more UTIs over the past 6 months or 3 or more over the last 1 year; lower urinary tract anatomical anomaly e.g., clinically significant urethral and/or bladder obstruction; pelvic radiotherapy
• History within prior 3 months: Types I or II bacterial prostatitis, infective urethritis; infective epididymo-orchitis, active genital herpes
• History within prior 6 weeks: Bacterial cystitis
• Current history of: Proven genitourinary infection; any sexually transmitted disease including Chlamydia, symptomatic urinary tract stone
• Have undergone the following treatments: radial prostatectomy, augmentation cytoplasty, cystectomy or other genitor-urinary surgery not otherwise specified, neurectomy
• Have undergone the following treatments less than 6 months prior to screen: Urogenital surgery such as, prostate surgery or treatment (e.g., TURP), other bladder or urethral surgery which could interfere with bladder or prostate function
• Have undergone the following treatments less than 3 months prior to screen: Therapeutic urethrotomy or dilatation, vasectomy, epididymectomy
• Have undergone the following treatments less than 6 weeks prior to screen: Prostate biopsy, hydrodistention, rigid cystoscopy, therapeutic prostatic massage, external neuromodulation e.g. TENS machine or acupuncture unless otherwise specified
• Have undergone the following treatments less than 2 weeks prior to screen: Urodynamics (cystometrogram), flexible cystoscopy, bladder biopsy
• History of allergic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein or hypersensitivity to any ingredients of the formulation
• Intolerant of or currently taking acetaminophen/paracetamol
• Have indwelling urinary catheters
• Have passive urinary continence
• Have taken study medication within 30 days of screening
• Have a resting SBP >160 mmHg or DBP >100 mm Hg
• Have neurological disease or psychiatric disorders
• Have significant cardiac disease
• Have a history of alcohol or drug abuse in the past 2 years
• Have active hepatitis B or C

Clinical Innovations
3545 Howard Way, Suite 200
Costa Mesa, CA 92626
Phone: 866-4STUDY1 (866-478-8391)

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