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NCT00644553 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Abbott.

Completed
Registry status
Phase 3
Development phase
437
Enrollment target

NCT00644553: Completed Phase 3 study, sponsored by Abbott.

NCT00644553 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 437 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00644553, a Phase 3 study, has completed, sponsored by Abbott.

COMPLETED
Registry status
Phase 3
Development phase
437 participants
Enrollment target

Study 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).

Interventions

  • DRUG Amoxicillin
  • DRUG Clarithromycin

Trial Details

FieldValue
Enrollment Target 437 participants
Start Date 2003-05
Phase Phase 3
Abbott

181 total trials

What the finished NCT00644553 record still lists

NCT00644553 is an interventional study that assigns participants to a tested intervention. The registered 437 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 (43% lower).

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

NCT00644553 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00644553 about?

NCT00644553 is a clinical study titled "Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis". 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).

What is the current status of trial NCT00644553?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 437 participants. The study started on 2003-05.

What interventions are being tested in trial NCT00644553?

The interventions under investigation include: Amoxicillin (DRUG), Clarithromycin (DRUG).

Who is sponsoring clinical trial NCT00644553?

This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00644553's enrollment target sits among peer trials

437 874th of 2000 higher than 1,127 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 NCT00644553, the US trial registry maintained by the National Library of Medicine. NCT00644553 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.