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The Clinical Efficacy of Non-Steroidal Anti-Inflammation Drugs in Patients With Benign Prostatic Hyperplasia
This study is currently recruiting participants.
Study NCT00687388   Information provided by Samsung Medical Center
First Received: May 27, 2008   Last Updated: July 5, 2009   History of Changes

May 27, 2008
July 5, 2009
May 2008
October 2009   (final data collection date for primary outcome measure)
The changes of International Prostatic Symptom Scores after medications [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00687388 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
The Clinical Efficacy of Non-Steroidal Anti-Inflammation Drugs in Patients With Benign Prostatic Hyperplasia
The Clinical Efficacy of Non-Steroidal Anti-Inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial

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

 
Phase IV
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • 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)
    Other Names:
    • tamsulosin
    • alfuzosin
    • doxazosin
    • terazosin
  • Drug: celecoxib
    200mg daily for 8 weeks
    Other Name: celecoxib
  • 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
    Other Names:
    • tamsulosin and celecoxib
    • alfuzosin and celecoxib
    • doxazosin and celecoxib
    • terazosin and celecoxib
  • Alpha-blocker: Active Comparator
    Alpha-blocker only
    Intervention: Drug: selective alpha 1-blockers
  • NSAID: Active Comparator
    NSAID only
    Intervention: Drug: celecoxib
  • alpha-blocker and NSAID: Experimental
    Combination treatment of alpha-blocker and NSAID
    Intervention: Drug: alpha-blocker and NSAID

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Male
50 Years to 80 Years
No
Contact: Kyu-Sung Lee, Ph.D., M.D. 82-2-3410-3559 ksleedr@skku.edu
Korea, Republic of
 
NCT00687388
Kyu-Sung Lee, Samsung Medical Center
2006-07-084
Samsung Medical Center
The Korean Urological Association
Principal Investigator: Kyu-Sung Lee, Ph.D., M.D. Samsung Medical Center
Samsung Medical Center
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP