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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01436578
First received: September 16, 2011
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This study will examine the safety and efficacy of posaconazole in general use in Korea.


Condition Intervention
Fungal Infections
Drug: Posaconazole oral suspension 40 mg/mL

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of NOXAFIL Oral Suspension in Usual Practice

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants with Serious Adverse Experiences [ Time Frame: During treatment and for 30 days following cessation of treatment ] [ Designated as safety issue: Yes ]
  • Number of participants with drug-related adverse experiences [ Time Frame: During treatment and for 30 days following cessation of treatment ] [ Designated as safety issue: Yes ]
  • Number of participants with unexpected drug-related adverse experiences [ Time Frame: During treatment and for 30 days following cessation of treatment ] [ Designated as safety issue: Yes ]
  • Number of participants with Non-Serious Adverse Experiences [ Time Frame: During treatment and for 30 days following cessation of treatment ] [ Designated as safety issue: Yes ]
  • Number of Participants with Responses of Improved, Not Improved, and Worsened [ Time Frame: After at least 14 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 273
Study Start Date: February 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: NOXAFIL

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Treated with posaconazole oral suspension within current local label

Exclusion Criteria:

  • Contraindication to posaconazole oral suspension according to current local label
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01436578     History of Changes
Other Study ID Numbers: P08547, MK-5592-091
Study First Received: September 16, 2011
Last Updated: December 6, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 23, 2014