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Trial record 85 of 398 for:    CLARITHROMYCIN

Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00644553
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE March 22, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date March 27, 2008
Study Start Date  ICMJE May 2003
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
Clinical Response [ Time Frame: 33 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
Radiographic Response [ Time Frame: 33 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
Official Title  ICMJE A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets vs. Amoxicillin-Clavulanate for the Treatment of Subjects With Acute Bacterial Sinusitis
Brief Summary To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Bacterial Sinusitis (ABS)
Intervention  ICMJE
  • Drug: Clarithromycin
    Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
    Other Names:
    • ABT-268
    • Biaxin
  • Drug: Amoxicillin
    Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
    Other Name: amoxicillin-clavulanate
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Clarithromycin
  • Active Comparator: B
    Intervention: Drug: Amoxicillin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2008)
437
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The female must be non-lactating and at no risk for pregnancy.
  • Subject must have a diagnosis of ABS. The diagnosis must be based on the following:

    • A sinus radiograph (Water's view) or CT scan with evidence of maxillary opacification or
    • Air/fluid levels purulent discharge from the nose
    • At least two of the following additional signs and symptoms lasting longer than seven days prior to and no longer than 28 days before Evaluation 1.
    • A pre-treatment sample from a sinus puncture or
    • Middle meatus endoscopy must be obtained for bacterial aerobic culture
    • Susceptibility testing (applicable only for selected investigative sites).
  • Subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact.

Exclusion Criteria:

  • A medical history of hypersensitivity or allergic reactions to clarithromycin, erythromycin, amoxicillin/clavulanate, any penicillin or any of the macrolide antibiotics.
  • History of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction.
  • Females who are pregnant or lactating.
  • Subject has either of the following:

    • Chronic sinusitis (signs and symptoms lasting longer than 28 days immediately prior to Evaluation 1)
    • Significant anatomical abnormalities of the sinuses any other infection or
    • Condition which necessitates use of a concomitant systemic antibiotic.
  • Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
  • Any underlying condition/disease, that would be likely to interfere with the completion of the course of study drug therapy or follow-up.
  • Known significant renal or hepatic impairment (or disease).
  • Subject who has taken: a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration.
  • Immunocompromised subjects (e.g., neutropenic subjects).
  • Subjects with known HIV infection.
  • Treatment with any other investigational drug within 4 weeks prior to study drug administration.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Greece,   Hungary,   Italy,   Lithuania,   Poland,   Romania,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644553
Other Study ID Numbers  ICMJE M02-524
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angela M Nilius, PhD, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott
Verification Date March 2008

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