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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01843946
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : May 1, 2013
Information provided by (Responsible Party):
Hyun-Sop Choe, The Catholic University of Korea

Brief 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.

Condition or disease
Chronic Prostatitis Chronic Pelvic Pain Syndrome

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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Study Type : Observational
Actual Enrollment : 75 participants
Time Perspective: Prospective
Study Start Date : March 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01843946

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Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Korea, Republic of, 442-723
Sponsors and Collaborators
The Catholic University of Korea
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Principal Investigator: Hyun-Sop Choe, Dr Saint Vincent's Hospital, Korea
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hyun-Sop Choe, Doctor, The Catholic University of Korea Identifier: NCT01843946    
Other Study ID Numbers: Rulid-2011
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Pelvic Pain
Chronic Disease
Pathologic Processes
Neurologic Manifestations
Prostatic Diseases
Disease Attributes