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CompletedNCT01843946Updated May 1, 2013

Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

An observational study in Chronic Prostatitis and Chronic Pelvic Pain Syndrome, sponsored by The Catholic University of Korea. Completed at 1 site in Korea, Republic of. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-01.

Sponsored by The Catholic University of Korea · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
75
Sex
Male
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Study summary

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.

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Conditions studied

  • Chronic Prostatitis
  • Chronic Pelvic Pain Syndrome
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In context

Prostatitis

83 studies on the registry are indexed under Prostatitis; 9 are open to participants now.

This study's enrollment of 75 is below the median of 300 across 15 observational studies indexed under Prostatitis.

Browse Prostatitis studies →

Lead sponsor

The Catholic University of Korea is the lead sponsor of 150 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

75

Inclusion criteria

  • Diagnosis of category IIIa of IIIb chronic prostatitis
  • NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. NIH-CPSI score

    Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.

    Time frame: 12 weeks

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Study locations

1 site
  • The Catholic University of Korea, St. Vincent's Hospital
    Suwon, 442-723, Korea, Republic of
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01843946
Lead sponsor
The Catholic University of Korea
Responsible party
Hyun-Sop Choe (Doctor, The Catholic University of Korea) — Principal investigator
First posted
May 1, 2013
Start date
Mar 2011
Primary completion
Jul 2012
Completion
Jul 2012
Last update
May 1, 2013

Study contacts

Hyun-Sop Choe, Dr
principal investigator · Saint Vincent's Hospital, Korea
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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