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

Fungal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436578
• Other study ID #: P08547
• Secondary ID: MK-5592-091
• Status: Completed
• Phase: N/A
• First received: September 16, 2011
• Last updated: July 6, 2015
• Start date: February 2012
• Est. completion date: November 2013

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Treated with posaconazole oral suspension within current local label

Exclusion Criteria:

• Contraindication to posaconazole oral suspension according to current local label

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fungal Infections
• Mycoses

Intervention

Drug:
• Posaconazole oral suspension 40 mg/mL
Posaconazole oral suspension prescribed according to the current local label

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Serious Adverse Experiences		During treatment and for 30 days following cessation of treatment	Yes
Primary	Number of participants with drug-related adverse experiences		During treatment and for 30 days following cessation of treatment	Yes
Primary	Number of participants with unexpected drug-related adverse experiences		During treatment and for 30 days following cessation of treatment	Yes
Primary	Number of participants with Non-Serious Adverse Experiences		During treatment and for 30 days following cessation of treatment	Yes
Primary	Number of Participants with Responses of Improved, Not Improved, and Worsened		After at least 14 days of treatment	No