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NCT00644293 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
598
Enrollment target

NCT00644293: Completed Phase 3 study, sponsored by Pfizer.

NCT00644293 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 598 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00644293, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
598 participants
Enrollment target

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.

Interventions

  • DRUG placebo
  • DRUG azithromycin (Zithromax)
  • DRUG azithromycin SR

Trial Details

FieldValue
Enrollment Target 598 participants
Start Date 2003-01
Est. Completion 2004-04
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT00644293 record still lists

NCT00644293 is an interventional study that assigns participants to a tested intervention. The registered 598 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 (23% lower).

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT00644293 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00644293 about?

NCT00644293 is a clinical study titled "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". 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.

What is the current status of trial NCT00644293?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 598 participants. The study started on 2003-01. Estimated completion is 2004-04.

What interventions are being tested in trial NCT00644293?

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

Who is sponsoring clinical trial NCT00644293?

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 NCT00644293's enrollment target sits among peer trials

598 640th of 2000 higher than 1,361 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 NCT00644293, the US trial registry maintained by the National Library of Medicine. NCT00644293 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.