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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
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:
Hyperplasia
Inflammation
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Adrenergic alpha-Antagonists
Alfuzosin
Anti-Inflammatory Agents, Non-Steroidal
Celecoxib
Doxazosin
Tamsulosin
Terazosin
Adrenergic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic Antagonists
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antihypertensive Agents
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014