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OpenTrials
Completed

NCT Number: NCT01843946

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

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.

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Key information

Conditions

Chronic Prostatitis Chronic Pelvic Pain Syndrome

Sex eligibility

Male

Study type

Observational

Primary location

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

Suwon, 442-723, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 1, 2013
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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