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

Chronic Pelvic Pain Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843946
• Other study ID #: Rulid-2011
• Status: Completed
• Phase: N/A
• First received: April 27, 2013
• Last updated: April 30, 2013
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2013
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Pelvic Pain Syndrome
• Chronic Prostatitis
• Pelvic Pain
• Prostatitis

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIH-CPSI score	Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.	12 weeks	Yes