The Clinical Efficacy of Non-Steroidal Anti-Inflammation Drugs in Patients With Benign Prostatic Hyperplasia - Full Text View

Sponsor:	Samsung Medical Center
Collaborator:	The Korean Urological Association
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00687388

Purpose

Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: selective alpha 1-blockers Drug: celecoxib Drug: alpha-blocker and NSAID	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Clinical Efficacy of Non-Steroidal Anti-Inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial

Resource links provided by NLM:

Drug Information available for: Terazosin Terazosin hydrochloride dihydrate Doxazosin Doxazosin mesylate Alfuzosin hydrochloride Alfuzosin Tamsulosin Tamsulosin hydrochloride Celecoxib

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

The changes of International Prostatic Symptom Scores after medications [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The changes of voiding frequencies after medications [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The changes of 'ICS male questionnaire-short form' after medications [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Patient perception of treatment benefit questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The changes of 'patient perception of bladder condition' after medications [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The changes of maximum flow rate and postvoid residuals after medications [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The changes of serum PSA levels after medications [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The changes of WBC counts on the expressed prostatic secretions after medications [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complications [ Time Frame: During all study periods ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Alpha-blocker: Active Comparator Alpha-blocker only	Drug: selective alpha 1-blockers Continued medication that the patient had before the enrollment of this study (tamsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks)
NSAID: Active Comparator NSAID only	Drug: celecoxib 200mg daily for 8 weeks
alpha-blocker and NSAID: Experimental Combination treatment of alpha-blocker and NSAID	Drug: alpha-blocker and NSAID amsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks and celecoxib 200mg daily for 8 weeks

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Who had the treatment of BPH with alpha-1 blockers for more than 3 months
Who have the IPSS(International Prostatic Symptom Score) >= 15
Who have the maximum flow rate(Qmax) < 15 with voided volume > 150mL
Who have the PPBC(patient's perception of bladder condition) >= 3 (The PPBC was assessed by the use of a six point ordered categorical scale(1-6 point). The higher score means the higher bother)
Who had the PSA level < 4 ng/mL within 6 months (But, the patient who are revealed not to have prostate cancer by prostate biopsy can be included even if he had PSA level of 4-10 ng/mL)
Who underwent the transrectal ultrasound of prostate within 6 months
Who can understand this study and can give the informed consent

Exclusion Criteria:

Who had regular intake of 5-alpha reductase inhibitor or NSAID within 6 months before screening
Who have peptic ulcer and/or asthma
Who have urologic malignancies such as prostate cancer and bladder cancer
Who have urethral strictures, large bladder diverticuli, and bladder neck contractures
Who had surgical treatment for BPH
Who have histories of bladder and/or urethra
Who have serum PSA level more than 10 ng/ml
Who have histories of orthostatic hypotension
Who have serum creatinine level more than 2.0 mg/dl
Who have serum ALT and/or AST level more than 1.5 times of normal upper limit
Who have heart failure
Who have histories of bacterial prostatitis within 1 year
Who have histories of active urinary tract infection within 1 month
Who have histories of the biopsy of bladder and prostate within 1 month
Who are unable to void
Who use pads because of incontinences
Who have hypersensitivities for alpha blockers that include quinazoline, NSAID, aspirin, sulfonamide
Who have histories of unstable angina, myocardial infarction, and cerebrovascular accident within 6 months
Who have neurogenic bladder due to multiple sclerosis, Parkinson's disease, Spinal injuries and etc.
Who have thinking disturbances
Who have histories of abuses of alcohol and/or other drugs
Who seem to be not fit to this study by the decision of investigators

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687388

Contacts

Contact: Kyu-Sung Lee, Ph.D., M.D.

82-2-3410-3559

ksleedr@skku.edu

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee ksleedr@skku.edu
Principal Investigator: Kyu-Sung Lee, Ph.D., M.D.
Sub-Investigator: Deok Hyun Han, M.D.
Asan Medical Center	Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Myung-Soo Choo, Ph.D., M.D. mschoo@amc.seoul.kr
Principal Investigator: Myung-Soo Choo, Ph.D., M.D.
Severance Hospital	Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jang Hwan Kim, Ph.D., M.D. jkim@yuhs.ac
Principal Investigator: Jang Hwan Kim, Ph.D., M.D.

Sponsors and Collaborators

Samsung Medical Center

The Korean Urological Association

Investigators

Principal Investigator:

Kyu-Sung Lee, Ph.D., M.D.

Samsung Medical Center

More Information

Publications:

Kramer G, Steiner GE, Handisurya A, Stix U, Haitel A, Knerer B, Gessl A, Lee C, Marberger M. Increased expression of lymphocyte-derived cytokines in benign hyperplastic prostate tissue, identification of the producing cell types, and effect of differentially expressed cytokines on stromal cell proliferation. Prostate. 2002 Jun 1;52(1):43-58.

Untergasser G, Madersbacher S, Berger P. Benign prostatic hyperplasia: age-related tissue-remodeling. Exp Gerontol. 2005 Mar;40(3):121-8. Epub 2005 Jan 22. Review.

Lee KL, Peehl DM. Molecular and cellular pathogenesis of benign prostatic hyperplasia. J Urol. 2004 Nov;172(5 Pt 1):1784-91. Review.

Handisurya A, Steiner GE, Stix U, Ecker RC, Pfaffeneder-Mantai S, Langer D, Kramer G, Memaran-Dadgar N, Marberger M. Differential expression of interleukin-15, a pro-inflammatory cytokine and T-cell growth factor, and its receptor in human prostate. Prostate. 2001 Dec 1;49(4):251-62.

Kakehi Y, Segawa T, Wu XX, Kulkarni P, Dhir R, Getzenberg RH. Down-regulation of macrophage inhibitory cytokine-1/prostate derived factor in benign prostatic hyperplasia. Prostate. 2004 Jun 1;59(4):351-6.

Steiner GE, Newman ME, Paikl D, Stix U, Memaran-Dagda N, Lee C, Marberger MJ. Expression and function of pro-inflammatory interleukin IL-17 and IL-17 receptor in normal, benign hyperplastic, and malignant prostate. Prostate. 2003 Aug 1;56(3):171-82.

Wang W, Bergh A, Damber JE. Chronic inflammation in benign prostate hyperplasia is associated with focal upregulation of cyclooxygenase-2, Bcl-2, and cell proliferation in the glandular epithelium. Prostate. 2004 Sep 15;61(1):60-72.

Kramer G, Marberger M. Could inflammation be a key component in the progression of benign prostatic hyperplasia? Curr Opin Urol. 2006 Jan;16(1):25-9. Review.

Rohrmann S, De Marzo AM, Smit E, Giovannucci E, Platz EA. Serum C-reactive protein concentration and lower urinary tract symptoms in older men in the Third National Health and Nutrition Examination Survey (NHANES III). Prostate. 2005 Jan 1;62(1):27-33.

Araki T, Yokoyama T, Kumon H. Effectiveness of a nonsteroidal anti-inflammatory drug for nocturia on patients with benign prostatic hyperplasia: a prospective non-randomized study of loxoprofen sodium 60 mg once daily before sleeping. Acta Med Okayama. 2004 Feb;58(1):45-9.

Responsible Party:	Samsung Medical Center ( Kyu-Sung Lee )
Study ID Numbers:	2006-07-084
Study First Received:	May 27, 2008
Last Updated:	July 5, 2009
ClinicalTrials.gov Identifier:	NCT00687388 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:

Cyclooxygenase 2 Inhibitors
Alpha Blockers
Treatment Outcome

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Prostatic Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Pathologic Processes
Prostatic Hyperplasia
Sensory System Agents
Therapeutic Uses
Tamsulosin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Celecoxib
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Cardiovascular Agents
Genital Diseases, Male
Antihypertensive Agents
Pharmacologic Actions
Doxazosin
Terazosine
Inflammation
Hyperplasia
Alfuzosin
Analgesics, Non-Narcotic
Adrenergic Antagonists

ClinicalTrials.gov processed this record on March 18, 2010