The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia

This study has been withdrawn prior to enrollment.
(in order to prepare a new clinical trial to evaluate with pathological change)
Sponsor:
Collaborator:
The Korean Urological Association
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00687388
First received: May 27, 2008
Last updated: June 7, 2013
Last verified: June 2013
  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 4

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:


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 ]

Enrollment: 0
Study Start Date: May 2008
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alpha-blocker
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)
Other Names:
  • tamsulosin
  • alfuzosin
  • doxazosin
  • terazosin
Active Comparator: NSAID
NSAID only
Drug: celecoxib
200mg daily for 8 weeks
Other Name: celecoxib
Experimental: alpha-blocker and NSAID
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
Other Names:
  • tamsulosin and celecoxib
  • alfuzosin and celecoxib
  • doxazosin and celecoxib
  • terazosin and celecoxib

  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

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Severance Hospital
Seoul, Korea, Republic of, 120-752
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:

Responsible Party: KYU-SUNG LEE, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00687388     History of Changes
Other Study ID Numbers: 2006-07-084
Study First Received: May 27, 2008
Last Updated: June 7, 2013
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:
Prostatic Hyperplasia
Hyperplasia
Inflammation
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Adrenergic alpha-Antagonists
Alfuzosin
Terazosin
Doxazosin
Tamsulosin
Anti-Inflammatory Agents, Non-Steroidal
Celecoxib
Cyclooxygenase 2 Inhibitors
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on April 16, 2014