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A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00249210
First received: November 4, 2005
Last updated: June 8, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection of the sinuses.


Condition Intervention Phase
Sinusitis
Maxillary Sinusitis
Drug: levofloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With Amoxicillin/Clavulanate Potassium in the Treatment of Acute Sinusitis in Adults

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Clinical response rate (a reduction in signs and symptoms, and stabilization/improvement of sinus x-ray results) at post-therapy visit, 2 - 5 days after the last dose of study drug

Secondary Outcome Measures:
  • Incidence of adverse events; change in physical examination, and laboratory tests from the start of the study to after treatment

Enrollment: 614
Study Start Date: August 1993
Study Completion Date: July 1994
Detailed Description:

Levofloxacin is an antibacterial agent used for the treatment of many types of severe infections with rapid onset and brief duration in adults. This is a randomized, open-label, parallel group, multicenter study to determine the safety and effectiveness of levofloxacin (500 mg tablets once daily by mouth for 10 - 14 days) compared with amoxicillin/clavulanate (500 mg/125 mg tablets by mouth every 8 hours for 10 - 14 days) in adults with rapid onset of severe inflammation/infection of the sinuses. The study consists of 4 visits: one visit for screening and enrollment, and three visits to assess the safety and effectiveness of treatment (one telephone contact during Days 3 - 6 of the study [if no significant improvement in symptoms has occurred by that time, a visit is scheduled]; one visit [post-therapy] 2 - 5 days after the last dose of the study drug; and one visit [post-study] 28 - 32 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 6 weeks. The primary measure of effectiveness is assessed by the clinical response rate after the completion of treatment (a reduction in the signs and symptoms, and by stabilization or improvement in x-ray findings). Safety evaluations (incidence of adverse events, physical examination, and laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with amoxicillin/clavulanate potassium in adults with rapid onset of severe inflammation/infection of the sinuses. 500 mg tablets of levofloxacin by mouth once daily, or 500 mg/125 mg amoxicillin/clavulanate tablets by mouth every 8 hours. The duration of treatment is 10 - 14 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rapid onset of severe inflammation/infection of the sinuses, as indicated by: fever, headache, discharge from the nose containing pus, facial pain, or tenderness in the area of the cheek bone
  • x-ray at the start of the trial consistent with the diagnosis of severe inflammation/infection of the sinuses
  • able to take oral medications

Exclusion Criteria:

  • Patients with symptoms of sinusitis that has persisted longer than 4 weeks or who have had more than 2 previous episodes of rapid onset of severe inflammation/infection of the sinuses within 12 months prior to the trial
  • previous allergic or serious adverse reaction to similar antibiotics
  • specific blood and urine test results indicating kidney problems
  • requirement of an antibiotic medication taken internally in addition to the study drug or have taken antibiotic medication within 48 hours prior to the start of the study and have experienced improvement
  • seizure disorders or any condition requiring tranquilizers.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249210

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00249210     History of Changes
Other Study ID Numbers: CR005485
Study First Received: November 4, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Sinusitis
respiratory tract diseases
nose diseases
respiratory tract infections
paranasal sinus diseases
antibacterial agents
quinolones
levofloxacin

Additional relevant MeSH terms:
Maxillary Sinusitis
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014