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NCT00643149 · ClinicalTrials.gov registry record · Phase 3

A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
693
Enrollment target

NCT00643149: Completed Phase 3 study, sponsored by Pfizer.

NCT00643149 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 693 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00643149, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
693 participants
Enrollment target

Study Summary

The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.

Interventions

  • DRUG amoxicillin
  • DRUG azithromycin SR

Trial Details

FieldValue
Enrollment Target 693 participants
Start Date 2003-05
Est. Completion 2004-03
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT00643149 record still lists

NCT00643149 is an interventional study that assigns participants to a tested intervention. The registered 693 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).

The record links to 0 conditions, and to 2 interventions - of which amoxicillin is the first listed.

NCT00643149 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00643149 about?

NCT00643149 is a clinical study titled "A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children". The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.

What is the current status of trial NCT00643149?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 693 participants. The study started on 2003-05. Estimated completion is 2004-03.

What interventions are being tested in trial NCT00643149?

The interventions under investigation include: amoxicillin (DRUG), azithromycin SR (DRUG).

Who is sponsoring clinical trial NCT00643149?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00643149's enrollment target sits among peer trials

693 519th of 2000 higher than 1,481 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00643149, the US trial registry maintained by the National Library of Medicine. NCT00643149 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.