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

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.

Study Overview

• Status: Completed
• Conditions: Fungal Infections
• Intervention / Treatment: Drug: Posaconazole oral suspension 40 mg/mL

• Study Type: Observational
• Enrollment (Actual): 273

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants enrolled will be all who are treated with posaconazole oral suspension per the current local label by participating investigators during the pre-specified surveillance period.

Description

Inclusion Criteria:

• Treated with posaconazole oral suspension within current local label

Exclusion Criteria:

• Contraindication to posaconazole oral suspension according to current local label

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants; All participants treated with posaconazole oral suspension during the pre-specified surveillance period.	Drug: Posaconazole oral suspension 40 mg/mL; Posaconazole oral suspension prescribed according to the current local label; Other Names: NOXAFIL

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 16, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (Estimate): September 19, 2011

Study Record Updates

• Last Update Posted (Estimate): July 7, 2015
• Last Update Submitted That Met QC Criteria: July 6, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; 14-alpha Demethylase Inhibitors; Trypanocidal Agents; Posaconazole
• Other Study ID Numbers: P08547; MK-5592-091 (Other Identifier: Merck protocol number)