NCT00276042 is a Phase 2 clinical trial of Faropenem Medoxomil in Otitis Media, sponsored by Replidyne.

Who is sponsoring NCT00276042?

NCT00276042 is sponsored by Replidyne.

What drugs are being tested in NCT00276042?

Interventions in NCT00276042: Faropenem Medoxomil.

What condition does NCT00276042 study?

NCT00276042 studies Otitis Media.

Is NCT00276042 still recruiting?

NCT00276042 is currently completed. Last updated 1 February 2008.

Last reviewed 2008-02-01 · How we verify

NCT00276042

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prospective, Randomized, Investigator-Blind Trial to Evaluate the Bacteriologic Eradication, Safety and Tolerability, and Pharmacokinetics of Different Dosages of Faropenem Medoxomil BID for 10 Days in the Treatment of Acute Otitis Media

Completed Phase 2 Last updated 1 February 2008

What this trial tests

Phase 2 trial testing Faropenem Medoxomil in Otitis Media in 328 participants. Completed.

Timeline

1 January 2006

Primary endpoint
1 January 2007

Quick facts

Lead sponsor	Replidyne
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	328
Start date	1 January 2006
Primary completion	1 January 2007
Sites	2 locations across Costa Rica, Israel

Drugs / interventions tested

Faropenem Medoxomil — full drug profile →

Conditions studied

Otitis Media — all drugs for Otitis Media →

Sponsor

Replidyne

Who can join

Adults 6 Months to 7, any sex, with Otitis Media. 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.

To evaluate bacteriologic efficacy

Sponsor's own description

The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem

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:

Other recruiting trials for Otitis Media

Currently open trials in the same condition.

NCT06731660 — Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children · NA · active not recruiting
NCT05915078 — Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry · recruiting
NCT05641285 — Diagnostic Utility of Otosight Middle Ear Scope · active not recruiting
NCT06260618 — Effect of Chitodex Gel in Tympanoplasty Surgery · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00276042 (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 Replidyne
Last refreshed: 1 February 2008

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/NCT00276042.

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