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

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.

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Key information

Conditions

Fungal Infections Bacterial Infections and Mycoses Infections Mycoses

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Treated with posaconazole oral suspension within current local label

Exclusion criteria

Contraindication to posaconazole oral suspension according to current local label

Treatment and study plan

Posaconazole oral suspension 40 mg/mL

Drug

Posaconazole oral suspension prescribed according to the current local label

Other names: NOXAFIL

Primary outcomes

Number of participants with Serious Adverse Experiences

Time frame: During treatment and for 30 days following cessation of treatment
Number of participants with drug-related adverse experiences

Time frame: During treatment and for 30 days following cessation of treatment
Number of participants with unexpected drug-related adverse experiences

Time frame: During treatment and for 30 days following cessation of treatment
Number of participants with Non-Serious Adverse Experiences

Time frame: During treatment and for 30 days following cessation of treatment
Number of Participants with Responses of Improved, Not Improved, and Worsened

Time frame: After at least 14 days of treatment

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Sep 19, 2011
Registry last updated: Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed