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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00687388
• Other study ID #: 2006-07-084
• Status: Withdrawn
• Phase: Phase 4
• First received: May 27, 2008
• Last updated: June 7, 2013
• Start date: May 2008

Study information

• Verified date: June 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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)
• celecoxib
200mg daily for 8 weeks
• 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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	The Korean Urological Association

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of International Prostatic Symptom Scores after medications		8 weeks	No
Secondary	The changes of voiding frequencies after medications		8 weeks	No
Secondary	The changes of 'ICS male questionnaire-short form' after medications		8 weeks	No
Secondary	Patient perception of treatment benefit questionnaire		8 weeks	No
Secondary	The changes of 'patient perception of bladder condition' after medications		8 weeks	No
Secondary	The changes of maximum flow rate and postvoid residuals after medications		8 weeks	No
Secondary	The changes of serum PSA levels after medications		8 weeks	No
Secondary	The changes of WBC counts on the expressed prostatic secretions after medications		8 weeks	No
Secondary	Complications		During all study periods	Yes