Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)

Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of NOXAFIL Oral Suspension in Usual Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01436578

Enrollment

273

Registered

2011-09-19

Start date

2012-02-29

Completion date

2013-11-30

Last updated

2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal Infections

Brief summary

This study will examine the safety and efficacy of posaconazole in general use in Korea. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Interventions

DRUGPosaconazole oral suspension 40 mg/mL

Posaconazole oral suspension prescribed according to the current local label

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Treated with posaconazole oral suspension within current local label

Exclusion criteria

* Contraindication to posaconazole oral suspension according to current local label

Design outcomes

Primary

Measure	Time frame
Number of participants with Serious Adverse Experiences	During treatment and for 30 days following cessation of treatment
Number of participants with drug-related adverse experiences	During treatment and for 30 days following cessation of treatment
Number of participants with unexpected drug-related adverse experiences	During treatment and for 30 days following cessation of treatment
Number of participants with Non-Serious Adverse Experiences	During treatment and for 30 days following cessation of treatment
Number of Participants with Responses of Improved, Not Improved, and Worsened	After at least 14 days of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026