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Study of Long-Term Antibiotic Treatment in Reactive Arthritis

This study has been completed.
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00621387
First received: February 11, 2008
Last updated: NA
Last verified: November 2007
History: No changes posted

February 11, 2008
February 11, 2008
November 1993
Not Provided
Proportion of patients recovered from arthritis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Swollen joint count [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tender joint count [ Time Frame: 6 months ]
  • Ritchie index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Joint pain (visual analogue scale) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Serum C-reactive protein level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood erythrocyte sedimentation rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Long-Term Antibiotic Treatment in Reactive Arthritis
Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Reactive Arthritis
  • Drug: ofloxacin and roxithromycin
    150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
    Other Name: Tarivid and Surlid
  • Drug: placebo
    placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months
  • Experimental: 1
    ofloxacin and roxithromycin
    Intervention: Drug: ofloxacin and roxithromycin
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
June 1998
Not Provided

Inclusion Criteria:

  1. Diagnosis of acute reactive arthritis
  2. Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
  3. Age 18 or older

Exclusion Criteria:

  1. Allergy to quinolones or macrolides
  2. Treatment with systemic corticosteroids within 2 weeks
  3. Serum creatinine level elevated over the reference limit
  4. Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
  5. Current or planned pregnancy, or lack of contraception
  6. Known HIV positivity
  7. Blood leukocyte count less than 4.0x109/l
  8. Blood platelet count less than 100x109/l
  9. Lack of co-operation.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00621387
121-853-93
No
Not Provided
Helsinki University
Not Provided
Principal Investigator: Marjatta Leirisalo-Repo, MD Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital
Helsinki University
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP