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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
selective alpha 1-blockers
celecoxib
alpha-blocker and NSAID
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Cyclooxygenase 2 Inhibitors, Alpha Blockers, Treatment Outcome

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital
  • Samsung Medical Center
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Alpha-blocker

NSAID

alpha-blocker and NSAID

Arm Description

Alpha-blocker only

NSAID only

Combination treatment of alpha-blocker and NSAID

Outcomes

Primary Outcome Measures

The changes of International Prostatic Symptom Scores after medications

Secondary Outcome Measures

The changes of voiding frequencies after medications
The changes of 'ICS male questionnaire-short form' after medications
Patient perception of treatment benefit questionnaire
The changes of 'patient perception of bladder condition' after medications
The changes of maximum flow rate and postvoid residuals after medications
The changes of serum PSA levels after medications
The changes of WBC counts on the expressed prostatic secretions after medications
Complications

Full Information

First Posted
May 27, 2008
Last Updated
June 7, 2013
Sponsor
Samsung Medical Center
Collaborators
The Korean Urological Association
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1. Study Identification

Unique Protocol Identification Number
NCT00687388
Brief Title
The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia
Official Title
The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
in order to prepare a new clinical trial to evaluate with pathological change
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
The Korean Urological Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Cyclooxygenase 2 Inhibitors, Alpha Blockers, Treatment Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alpha-blocker
Arm Type
Active Comparator
Arm Description
Alpha-blocker only
Arm Title
NSAID
Arm Type
Active Comparator
Arm Description
NSAID only
Arm Title
alpha-blocker and NSAID
Arm Type
Experimental
Arm Description
Combination treatment of alpha-blocker and NSAID
Intervention Type
Drug
Intervention Name(s)
selective alpha 1-blockers
Other Intervention Name(s)
tamsulosin, alfuzosin, doxazosin, terazosin
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Description
200mg daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
alpha-blocker and NSAID
Other Intervention Name(s)
tamsulosin and celecoxib, alfuzosin and celecoxib, doxazosin and celecoxib, terazosin and celecoxib
Intervention Description
amsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks and celecoxib 200mg daily for 8 weeks
Primary Outcome Measure Information:
Title
The changes of International Prostatic Symptom Scores after medications
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The changes of voiding frequencies after medications
Time Frame
8 weeks
Title
The changes of 'ICS male questionnaire-short form' after medications
Time Frame
8 weeks
Title
Patient perception of treatment benefit questionnaire
Time Frame
8 weeks
Title
The changes of 'patient perception of bladder condition' after medications
Time Frame
8 weeks
Title
The changes of maximum flow rate and postvoid residuals after medications
Time Frame
8 weeks
Title
The changes of serum PSA levels after medications
Time Frame
8 weeks
Title
The changes of WBC counts on the expressed prostatic secretions after medications
Time Frame
8 weeks
Title
Complications
Time Frame
During all study periods

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D., M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
11992619
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. doi: 10.1002/pros.10084.
Results Reference
background
PubMed Identifier
15763388
Citation
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.
Results Reference
background
PubMed Identifier
15540721
Citation
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.
Results Reference
background
PubMed Identifier
11746271
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. doi: 10.1002/pros.10020.
Results Reference
background
PubMed Identifier
15065082
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. doi: 10.1002/pros.10365.
Results Reference
background
PubMed Identifier
12772186
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. doi: 10.1002/pros.10238.
Results Reference
background
PubMed Identifier
15287094
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. doi: 10.1002/pros.20061.
Results Reference
background
PubMed Identifier
16385197
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.
Results Reference
background
PubMed Identifier
15389816
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. doi: 10.1002/pros.20110.
Results Reference
background
PubMed Identifier
15157011
Citation
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.
Results Reference
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The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia

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