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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

NCT00644293 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2011-06-08

No results posted yet for this study

Summary

To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

Conditions

  • Pharyngitis
  • Tonsillitis

Interventions

DRUG

azithromycin (Zithromax)

azithromycin 500 mg tablet by mouth once daily for 3 days

DRUG

placebo

placebo

DRUG

azithromycin SR

azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose

DRUG

placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Completion
2004-04-30

Countries

  • United States
  • Belgium
  • Finland
  • France
  • Germany
  • India
  • Italy
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT00644293 on ClinicalTrials.gov