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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014