Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome - Full Text View

Purpose

The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH). The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis

Condition	Intervention	Phase
Prostatitis	Drug: Alfuzosin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized Multicenter Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of 10mg Alfuzosin in the Treatment of Chronic Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS) in Recently-Diagnosed and/or Newly-Symptomatic Alpha-blocker Naïve Patients

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Pain

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

NIH-CPSI Total Score

Secondary Outcome Measures:

Subscales of the NIH-CPSI
Symptom Assessment Form
Global Response Assessment
McGill Pain Questionnaire
Medical Outcomes Study Short Form 12
Hospital Anxiety and Depression Scale
International Index of Erectile Dysfunction
Male Sexual Health Questionnaire

Estimated Enrollment:	270
Study Start Date:	February 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The two primary objectives of this study are:

To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naïve CP/CPPS participants with respect to the primary endpoint in the NIH-CPSI.
To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants.

The proportion of "responders" in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo. Approximately 270 eligible patients, 135 per treatment arm, will be randomized and followed for a period of twelve (12) weeks after randomization. There will be four clinic visits.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participant has signed and dated the appropriate Informed Consent document.
Participant is male.
Participant is at least 18 years of age.
Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.
Symptoms bothersome enough to prompt a physician visit have been present for two years or less.

Exclusion Criteria:

Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 CFU/ml in mid-stream urine (VB2).
Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin HCL (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.
Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.
Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders.
Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.
Participant has uninvestigated, significant hematuria.
Participant has undergone TURP, TUIP, TUIBN, TUMT, TUNA, balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
Participant is currently taking exclusionary medications such as potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103402

Locations

United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Illinois
Northwestern U. Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Harvard Medical School- Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Washington
University of Washington- Harborview Medical Center
Seattle, Washington, United States, 98108
Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Study Director:	Leroy Nyberg, MD PhD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director:	John Kusek, PhD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Publications:

Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O'Leary MP, Pontari MA, McNaughton-Collins M, Shoskes DA, Comiter CV, Datta NS, Fowler JE Jr, Nadler RB, Zeitlin SI, Knauss JS, Wang Y, Kusek JW, Nyberg LM Jr, Litwin MS; Chronic Prostatitis Collaborative Research Network. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004 Oct 19;141(8):581-9.

Litwin MS. A review of the development and validation of the National Institutes of Health Chronic Prostatitis Symptom Index. Urology. 2002 Dec;60(6 Suppl):14-8; discussion 18-9. Review.

Schaeffer AJ; National Institute of Diabetes and Digestive and Kidney Diseases of the US National Institutes of Health. NIDDK-sponsored chronic prostatitis collaborative research network (CPCRN) 5-year data and treatment guidelines for bacterial prostatitis. Int J Antimicrob Agents. 2004 Sep;24 Suppl 1:S49-52.

Schaeffer AJ, Landis JR, Knauss JS, Propert KJ, Alexander RB, Litwin MS, Nickel JC, O'Leary MP, Nadler RB, Pontari MA, Shoskes DA, Zeitlin SI, Fowler JE Jr, Mazurick CA, Kishel L, Kusek JW, Nyberg LM; Chronic Prostatitis Collaborative Research Network Group. Demographic and clinical characteristics of men with chronic prostatitis: the national institutes of health chronic prostatitis cohort study. J Urol. 2002 Aug;168(2):593-8.

Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6.

Schaeffer AJ, Datta NS, Fowler JE Jr, Krieger JN, Litwin MS, Nadler RB, Nickel JC, Pontari MA, Shoskes DA, Zeitlin SI, Hart C; Chronic Prostatitis Collaborative Research Network. Overview summary statement. Diagnosis and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Urology. 2002 Dec;60(6 Suppl):1-4. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, Shoskes DA, Litwin MS, Alexander RB, White PC, Berger R, Nadler R, O'Leary M, Liong ML, Zeitlin S, Chuai S, Landis JR, Kusek JW, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008 Dec 18;359(25):2663-73.

ClinicalTrials.gov Identifier:	NCT00103402 History of Changes
Other Study ID Numbers:	cp/cpps (IND), RFA-DK-03-004
Study First Received:	February 7, 2005
Last Updated:	April 25, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Prostatitis
Non-bacterial Prostatitis
Prostatodynia
Alfuzosin
Alpha-adrenergic blocker

Additional relevant MeSH terms:

Pelvic Pain
Prostatitis
Chronic Disease
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes
Adrenergic alpha-Antagonists
Alfuzosin

Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013