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

NCT ID: NCT01843946

Last Updated: 2013-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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

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Chronic Prostatitis Chronic Pelvic Pain Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Urinary tract infection or uropathogen within the past 12 months
* Serious medical problems
* Drug therapy that might affect lower urinary tract functions within the past 3 months
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Sop Choe

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun-Sop Choe, Dr

Role: PRINCIPAL_INVESTIGATOR

Saint Vincent's Hospital, Korea

Locations

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The Catholic University of Korea, St. Vincent's Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24462419 (View on PubMed)

Other Identifiers

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Rulid-2011

Identifier Type: -

Identifier Source: org_study_id

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