NCT01436578

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

September 16, 2011

Last Update Submit

July 6, 2015

Conditions

Fungal Infections

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

All Participants

All participants treated with posaconazole oral suspension during the pre-specified surveillance period.

Drug: Posaconazole oral suspension 40 mg/mL

Interventions

Posaconazole oral suspension 40 mg/mLDRUG

Posaconazole oral suspension prescribed according to the current local label

Also known as: NOXAFIL
All Participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Treated with posaconazole oral suspension within current local label

You may not qualify if:

  • Contraindication to posaconazole oral suspension according to current local label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mycoses

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 19, 2011

Study Start

February 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 7, 2015

Record last verified: 2015-07