NCT01843946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

April 27, 2013

Last Update Submit

April 30, 2013

Conditions

Chronic ProstatitisChronic Pelvic Pain Syndrome

Outcome Measures

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.

    12 weeks

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

75

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Suwon, 442-723, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24462419DERIVED

Study Officials

  • Hyun-Sop Choe, Dr

    Saint Vincent's Hospital, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 27, 2013

First Posted

May 1, 2013

Study Start

March 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 1, 2013

Record last verified: 2013-04

Locations

KR(1)