The Clinical Efficacy of Non-steroidal Anti-inflammation... | NCT00687388

Status Module

Name	Class
The Korean Urological Association	OTHER

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alpha-blocker	Active Comparator	Alpha-blocker only	Drug: selective alpha 1-blockers
NSAID	Active Comparator	NSAID only	Drug: celecoxib
alpha-blocker and NSAID	Experimental	Combination treatment of alpha-blocker and NSAID	Drug: alpha-blocker and NSAID

Interventions

Name	Type	Description	Arm Group Labels	Other Names
selective alpha 1-blockers	Drug	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)

Measure	Description	Time Frame
The changes of International Prostatic Symptom Scores after medications		8 weeks

Measure	Description	Time Frame
The changes of voiding frequencies after medications		8 weeks
The changes of 'ICS male questionnaire-short form' after medications		8 weeks
Patient perception of treatment benefit questionnaire

Eligibility Module

Eligibility 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

Name	Affiliation	Role
Kyu-Sung Lee, Ph.D., M.D.	Samsung Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital		Seoul		120-752	South Korea
Samsung Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11992619	Background	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. doi: 10.1002/pros.10084.
15763388

ID	Term
D011470	Prostatic Hyperplasia

ID	Term
D000077409	Tamsulosin
C047638	alfuzosin
D017292	Doxazosin
C041226	Terazosin
D000068579	Celecoxib
D000317	Adrenergic alpha-Antagonists
D000894	Anti-Inflammatory Agents, Non-Steroidal

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011224	Prazosin
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D018674	Adrenergic Antagonists
D018663	Adrenergic Agents
D018377	Neurotransmitter Agents
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D045505	Physiological Effects of Drugs
D018712	Analgesics, Non-Narcotic
D000700	Analgesics
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents
D000893	Anti-Inflammatory Agents
D045506	Therapeutic Uses
D018501	Antirheumatic Agents