Benign Prostatic HyperplasiaPhase 4NCT00687388
The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia
A Phase 4 study testing selective alpha 1-blockers, celecoxib and alpha-blocker and NSAID in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center at 3 sites in South Korea.
Trial summary
Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- selective alpha 1-blockers, celecoxib and alpha-blocker and NSAID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesSouth Korea
- Study dates
- May 2008to Mar 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Severance Hospital
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul, 138-736
About this study
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
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- selective alpha 1-blockers, celecoxib, alpha-blocker and NSAID
- Keywords
- Cyclooxygenase 2 Inhibitors, Alpha Blockers, Treatment Outcome
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective alpha 1-blockersDrug
Also called tamsulosin, alfuzosin, doxazosin, terazosin
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)
celecoxibDrug
200mg daily for 8 weeks
alpha-blocker and NSAIDDrug
Also called tamsulosin and celecoxib, alfuzosin and celecoxib, doxazosin and celecoxib, terazosin and celecoxib
amsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks and celecoxib 200mg daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Alpha-blocker | Active comparator | Alpha-blocker only Receives: Drug: selective alpha 1-blockers |
| NSAID | Active comparator | NSAID only Receives: Drug: celecoxib |
| alpha-blocker and NSAID | Experimental | Combination treatment of alpha-blocker and NSAID Receives: Drug: alpha-blocker and NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of International Prostatic Symptom Scores after medications
Measured: 8 weeks
Secondary outcomes (8)
The changes of voiding frequencies after medications
Measured: 8 weeks
The changes of 'ICS male questionnaire-short form' after medications
Measured: 8 weeks
Patient perception of treatment benefit questionnaire
Measured: 8 weeks
The changes of 'patient perception of bladder condition' after medications
Measured: 8 weeks
The changes of maximum flow rate and postvoid residuals after medications
Measured: 8 weeks
The changes of serum PSA levels after medications
Measured: 8 weeks
The changes of WBC counts on the expressed prostatic secretions after medications
Measured: 8 weeks
Complications
Measured: During all study periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2012 (estimated)
Why it stopped: in order to prepare a new clinical trial to evaluate with pathological change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Urological Association
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D., M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687388
- Sponsor's protocol ID
- 2006-07-084
- Status last verified
- Jun 2013
- First submitted
- 27 May 2008
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11992619Untergasser 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.
PubMed 15763388Lee 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.
PubMed 15540721Handisurya 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.
PubMed 11746271Kakehi 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.
PubMed 15065082Steiner 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.
PubMed 12772186Wang 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.
PubMed 15287094Kramer 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.
PubMed 16385197Rohrmann 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.
PubMed 15389816Araki 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.
PubMed 15157011
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT00687388
- Acronym / sponsor ID
- 2006-07-084
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Cyclooxygenase 2 Inhibitors, Alpha Blockers, Treatment Outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: in order to prepare a new clinical trial to evaluate with pathological change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- The Korean Urological Association
- Study start
- May 2008
- Primary completion
- Mar 2012 (estimated)
- First posted
- 30 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alpha-blocker | Active comparator | Drug: selective alpha 1-blockersAlpha-blocker only |
| NSAID | Active comparator | Drug: celecoxibNSAID only |
| alpha-blocker and NSAID | Experimental | Drug: alpha-blocker and NSAIDCombination treatment of alpha-blocker and NSAID |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective alpha 1-blockersAlso: tamsulosin, alfuzosin, doxazosin, terazosinContinued 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 | Alpha-blocker |
| celecoxib200mg daily for 8 weeks | Drug | NSAID |
| alpha-blocker and NSAIDAlso: tamsulosin and celecoxib, alfuzosin and celecoxib, doxazosin and celecoxib, terazosin and celecoxibamsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks and celecoxib 200mg daily for 8 weeks | Drug | alpha-blocker and NSAID |
Primary outcome
The changes of International Prostatic Symptom Scores after medications
Time frame: 8 weeks
8 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- Background: PubMed 11992619Kramer 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.
- Background: PubMed 15763388Untergasser 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.
- Background: PubMed 15540721Lee 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.
- Background: PubMed 11746271Handisurya 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.
- Background: PubMed 15065082Kakehi 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.
- Background: PubMed 12772186Steiner 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.
- Background: PubMed 15287094Wang 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.
- Background: PubMed 16385197Kramer 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.
- Background: PubMed 15389816Rohrmann 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.
- Background: PubMed 15157011Araki 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.
Related trials for Benign Prostatic Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D., M.D. principal investigator
Samsung Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing selective alpha 1-blockers, celecoxib and alpha-blocker and NSAID in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of International Prostatic Symptom Scores after medications (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00687388, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.