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

NCT00687388 | Withdrawn Phase 4 DMC

• 1 other identifier: 2006-07-084
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia

Keywords

Cyclooxygenase 2 Inhibitors; Alpha Blockers; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• The changes of International Prostatic Symptom Scores after medications

  8 weeks

Secondary Outcomes (8)

• The changes of voiding frequencies after medications

  8 weeks

• The changes of 'ICS male questionnaire-short form' after medications

  8 weeks

• Patient perception of treatment benefit questionnaire

  8 weeks

• The changes of 'patient perception of bladder condition' after medications

  8 weeks

• The changes of maximum flow rate and postvoid residuals after medications

  8 weeks

Study Arms (3)

Alpha-blocker

ACTIVE COMPARATOR

Alpha-blocker only

Drug: selective alpha 1-blockers

NSAID

ACTIVE COMPARATOR

NSAID only

Drug: celecoxib

alpha-blocker and NSAID

EXPERIMENTAL

Combination treatment of alpha-blocker and NSAID

Drug: alpha-blocker and NSAID

Interventions

selective alpha 1-blockers DRUG

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)

Also known as: tamsulosin, alfuzosin, doxazosin, terazosin

Alpha-blocker

celecoxib DRUG

200mg daily for 8 weeks

NSAID

alpha-blocker and NSAID DRUG

amsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks and celecoxib 200mg daily for 8 weeks

Also known as: tamsulosin and celecoxib, alfuzosin and celecoxib, doxazosin and celecoxib, terazosin and celecoxib

alpha-blocker and NSAID

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• The Korean Urological Association: collaborator

Study Sites (3)

Severance Hospital

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (10)

• 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. doi: 10.1002/pros.10084.

  PMID: 11992619 BACKGROUND

• Untergasser G, Madersbacher S, Berger P. Benign prostatic hyperplasia: age-related tissue-remodeling. Exp Gerontol. 2005 Mar;40(3):121-8. doi: 10.1016/j.exger.2004.12.008. Epub 2005 Jan 22.

  PMID: 15763388 BACKGROUND

• Lee KL, Peehl DM. Molecular and cellular pathogenesis of benign prostatic hyperplasia. J Urol. 2004 Nov;172(5 Pt 1):1784-91. doi: 10.1097/01.ju.0000133655.71782.14.

  PMID: 15540721 BACKGROUND

• 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. doi: 10.1002/pros.10020.

  PMID: 11746271 BACKGROUND

• 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. doi: 10.1002/pros.10365.

  PMID: 15065082 BACKGROUND

• 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. doi: 10.1002/pros.10238.

  PMID: 12772186 BACKGROUND

• 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. doi: 10.1002/pros.20061.

  PMID: 15287094 BACKGROUND

• 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.

  PMID: 16385197 BACKGROUND

• 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. doi: 10.1002/pros.20110.

  PMID: 15389816 BACKGROUND

• 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. doi: 10.18926/AMO/32115.

  PMID: 15157011 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; alfuzosin; Doxazosin; Terazosin; Celecoxib; Adrenergic alpha-Antagonists; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Kyu-Sung Lee, Ph.D., M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2012
• Last Updated: June 10, 2013

Record last verified: 2013-06

Locations

KR (3)