Chronic ProstatitisNCT01843946
Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
An observational study of Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Jul 2012
- Phase
- Observational
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 75
Who may be able to join
- Diagnosis of category IIIa of IIIb chronic prostatitis
- NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15
Who cannot join
- Urinary tract infection or uropathogen within the past 12 months
- Serious medical problems
- NIH consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.)
- Drug therapy that might affect lower urinary tract functions within the past 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 442-723
About this study
Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. To explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac.
Read the detailed description
A total of 75 patients with CP/CPPS were randomized to three groups in open-label: group 1, ciprofloxacin; group 2, aceclofenac; and group 3, roxithromycin. The patients were treated for 4 weeks and were subsequently followed for 12 weeks. Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH-CPSI score
Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ProstatitisStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Sop Choe, The Catholic University of Korea
- Investigators
- Hyun-Sop Choe, Dr, Principal investigator, Saint Vincent's Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843946
- Sponsor's protocol ID
- Rulid-2011
- Status last verified
- Apr 2013
- First submitted
- 27 Apr 2013
- Last updated
- 1 May 2013
- Results posted
- No
Publications
Choe HS, Lee SJ, Han CH, Shim BS, Cho YH. Clinical efficacy of roxithromycin in men with chronic prostatitis/chronic pelvic pain syndrome in comparison with ciprofloxacin and aceclofenac: a prospective, randomized, multicenter pilot trial. J Infect Chemother. 2014 Jan;20(1):20-5. doi: 10.1016/j.jiac.2013.07.010. Epub 2013 Dec 11.
PubMed 24462419
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT01843946
- Acronym / sponsor ID
- Rulid-2011
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 May 2013 (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.
Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. To explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac.
Detailed description
A total of 75 patients with CP/CPPS were randomized to three groups in open-label: group 1, ciprofloxacin; group 2, aceclofenac; and group 3, roxithromycin. The patients were treated for 4 weeks and were subsequently followed for 12 weeks. Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 75
Key inclusion criteria (2 listed)
- Diagnosis of category IIIa of IIIb chronic prostatitis
- NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15
Key exclusion criteria (4 listed)
- Urinary tract infection or uropathogen within the past 12 months
- Serious medical problems
- NIH consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.)
- Drug therapy that might affect lower urinary tract functions within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NIH-CPSI score
Time frame: 12 weeks
Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
- Derived from this study: PubMed 24462419Choe HS, Lee SJ, Han CH, Shim BS, Cho YH. Clinical efficacy of roxithromycin in men with chronic prostatitis/chronic pelvic pain syndrome in comparison with ciprofloxacin and aceclofenac: a prospective, randomized, multicenter pilot trial. J Infect Chemother. 2014 Jan;20(1):20-5. doi: 10.1016/j.jiac.2013.07.010. Epub 2013 Dec 11.
Related trials for Chronic Prostatitis
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Pelvic Pain Syndrome (CPPS)
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.
Hyun-Sop Choe, Dr principal investigator
Saint Vincent's Hospital, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by The Catholic University of Korea at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NIH-CPSI score (time frame: 12 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 NCT01843946, which also lists 1 linked publication.
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 1 May 2013.