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NCT00100126

A Phase III, Investigator Blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of APC-231 Sprinkle QD for 7 Days vs Penicillin VK 10 mg/kg QID for 10 Days in Pediatric Patients With Streptococcus Pyogenes

Completed Phase 3 Last updated 23 October 2006
What this trial tests

Phase 3 trial testing Amoxicillin Pulsatile Release Multiparticluate Sprinkle in Pharyngitis in 500 participants. Completed in 1 June 2005.

Timeline
1 December 2004
1 June 2005

Quick facts

Lead sponsorAdvancis Pharmaceutical Corporation
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment500
Start date1 December 2004
Estimated completion1 June 2005
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Advancis Pharmaceutical Corporation — full company profile →

Who can join

Adults 6 Months to 12, any sex, with Pharyngitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Pharyngitis

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00100126.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing