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

Verified by: Samsung Medical Center, December 2011
First Received: May 27, 2008 | Last Updated: December 14, 2011 | Phase: Phase 4 | Start Date: May 2008
Overall Status: Recruiting | Estimated Enrollment: 60
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Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic...

Brief Summary

Official Title: “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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2012

Intervention(s) in this Clinical Trial

  • 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)
  • Drug: celecoxib
    • 200mg daily for 8 weeks
  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Alpha-blocker
    • Alpha-blocker only
  • Active Comparator: NSAID
    • NSAID only
  • Experimental: alpha-blocker and NSAID
    • Combination treatment of alpha-blocker and NSAID

Outcome Measures for this Clinical Trial

Primary Measures

  • The changes of International Prostatic Symptom Scores after medications
    • Time Frame: 8 weeks
      Safety Issue?: No

Secondary Measures

  • The changes of voiding frequencies after medications
    • Time Frame: 8 weeks
      Safety Issue?: No
  • The changes of 'ICS male questionnaire-short form' after medications
    • Time Frame: 8 weeks
      Safety Issue?: No
  • Patient perception of treatment benefit questionnaire
    • Time Frame: 8 weeks
      Safety Issue?: No
  • The changes of 'patient perception of bladder condition' after medications
    • Time Frame: 8 weeks
      Safety Issue?: No
  • The changes of maximum flow rate and postvoid residuals after medications
    • Time Frame: 8 weeks
      Safety Issue?: No
  • The changes of serum PSA levels after medications
    • Time Frame: 8 weeks
      Safety Issue?: No
  • The changes of WBC counts on the expressed prostatic secretions after medications
    • Time Frame: 8 weeks
      Safety Issue?: No
  • Complications
    • Time Frame: During all study periods
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Samsung Medical Center Other

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Kyu-Sung Lee, Ph.D., M.D. 82-2-3410-3559 ksleedr@skku.edu

Related Publications

References

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.

Untergasser G, Madersbacher S, Berger P. Benign prostatic hyperplasia: age-related tissue-remodeling. Exp Gerontol. 2005 Mar;40(3):121-8. Epub 2005 Jan 22. Review.

Lee KL, Peehl DM. Molecular and cellular pathogenesis of benign prostatic hyperplasia. J Urol. 2004 Nov;172(5 Pt 1):1784-91. Review.

Handisurya A, Steiner GE, Stix U, Ecker RC, Pfaffeneder-Mantai S, Langer D, Kramer G, Memaran-Dadgar N, Marberger M. Differential expression of interleukin-15, a pro-inflammatory cytokine and T-cell growth factor, and its receptor in human prostate. Prostate. 2001 Dec 1;49(4):251-62.

Kakehi Y, Segawa T, Wu XX, Kulkarni P, Dhir R, Getzenberg RH. Down-regulation of macrophage inhibitory cytokine-1/prostate derived factor in benign prostatic hyperplasia. Prostate. 2004 Jun 1;59(4):351-6.

Steiner GE, Newman ME, Paikl D, Stix U, Memaran-Dagda N, Lee C, Marberger MJ. Expression and function of pro-inflammatory interleukin IL-17 and IL-17 receptor in normal, benign hyperplastic, and malignant prostate. Prostate. 2003 Aug 1;56(3):171-82.

Wang W, Bergh A, Damber JE. Chronic inflammation in benign prostate hyperplasia is associated with focal upregulation of cyclooxygenase-2, Bcl-2, and cell proliferation in the glandular epithelium. Prostate. 2004 Sep 15;61(1):60-72.

Kramer G, Marberger M. Could inflammation be a key component in the progression of benign prostatic hyperplasia? Curr Opin Urol. 2006 Jan;16(1):25-9. Review.

Rohrmann S, De Marzo AM, Smit E, Giovannucci E, Platz EA. Serum C-reactive protein concentration and lower urinary tract symptoms in older men in the Third National Health and Nutrition Examination Survey (NHANES III). Prostate. 2005 Jan 1;62(1):27-33.

Araki T, Yokoyama T, Kumon H. Effectiveness of a nonsteroidal anti-inflammatory drug for nocturia on patients with benign prostatic hyperplasia: a prospective non-randomized study of loxoprofen sodium 60 mg once daily before sleeping. Acta Med Okayama. 2004 Feb;58(1):45-9.

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00687388

Study ID Number: 2006-07-084

ClinicalTrials.gov Identifier: NCT00687388

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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