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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
Phase 3 trial testing Amoxicillin Pulsatile Release Multiparticluate Sprinkle in Pharyngitis in 500 participants. Completed in 1 June 2005.
Quick facts
| Lead sponsor | Advancis Pharmaceutical Corporation |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 1 December 2004 |
| Estimated completion | 1 June 2005 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Amoxicillin Pulsatile Release Multiparticluate Sprinkle — full drug profile →
Conditions studied
- Pharyngitis — all drugs for Pharyngitis →
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.
- Bacteriological outcome at Test of Cure Visit
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.
Verify or expand the search:
- PubMed search for NCT00100126
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pharyngitis
Currently open trials in the same condition.
- NCT06859281 — Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers · Phase 1 · recruiting
- NCT06857890 — Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy · Phase 1 · recruiting
- NCT06843018 — Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray · Phase 2 · recruiting
- NCT06114706 — Best Assessment of Sore Throat and Antibiotic Prescribing · NA · recruiting
- NCT04471493 — Pediatric and Ambulatory Research in Infectious Diseases · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00100126 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Advancis Pharmaceutical Corporation
- Last refreshed: 23 October 2006
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