Study of Long-Term Antibiotic Treatment in Reactive Arthritis

NCT00621387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2008-02-22

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. The main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, Ritchie index, joint pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.

Conditions

  • Reactive Arthritis

Interventions

DRUG

ofloxacin and roxithromycin

150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months

DRUG

placebo

placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months

Sponsors & Collaborators

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Marjatta Leirisalo-Repo, MD · Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-11-30
Completion
1998-06-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00621387 on ClinicalTrials.gov