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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00687388
First Posted: May 30, 2008
Last Update Posted: June 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Korean Urological Association
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 KYU-SUNG LEE, Samsung Medical Center:

Primary Outcome Measures:
  • The changes of International Prostatic Symptom Scores after medications [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • The changes of voiding frequencies after medications [ Time Frame: 8 weeks ]
  • The changes of 'ICS male questionnaire-short form' after medications [ Time Frame: 8 weeks ]
  • Patient perception of treatment benefit questionnaire [ Time Frame: 8 weeks ]
  • The changes of 'patient perception of bladder condition' after medications [ Time Frame: 8 weeks ]
  • The changes of maximum flow rate and postvoid residuals after medications [ Time Frame: 8 weeks ]
  • The changes of serum PSA levels after medications [ Time Frame: 8 weeks ]
  • The changes of WBC counts on the expressed prostatic secretions after medications [ Time Frame: 8 weeks ]
  • Complications [ Time Frame: During all study periods ]

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
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

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687388


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
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
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: June 10, 2013
Last Verified: June 2013

Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
Cyclooxygenase 2 Inhibitors
Alpha Blockers
Treatment Outcome

Additional relevant MeSH terms:
Inflammation
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Tamsulosin
Doxazosin
Alfuzosin
Terazosin
Prazosin
Adrenergic alpha-Antagonists
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Urological Agents