Fungal InfectionsNCT01436578
Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)
An observational study of Fungal Infections, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fungal Infections
- What is being tested?
- Posaconazole oral suspension 40 mg/mL
- Type of treatment
- Pill or oral medicine
- How many people
- 273 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Treated with posaconazole oral suspension within current local label
Who cannot join
- Contraindication to posaconazole oral suspension according to current local label
About this study
Official title: 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.
- Conditions
- Fungal Infections
- Being tested
- Posaconazole oral suspension 40 mg/mL
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posaconazole oral suspension 40 mg/mLDrug
Also called NOXAFIL
Posaconazole oral suspension prescribed according to the current local label
| Study group | Role | What they receive |
|---|---|---|
| All Participants | All participants treated with posaconazole oral suspension during the pre-specified surveillance period. Receives: Drug: Posaconazole oral suspension 40 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Serious Adverse Experiences
Measured: During treatment and for 30 days following cessation of treatment
Number of participants with drug-related adverse experiences
Measured: During treatment and for 30 days following cessation of treatment
Number of participants with unexpected drug-related adverse experiences
Measured: During treatment and for 30 days following cessation of treatment
Number of participants with Non-Serious Adverse Experiences
Measured: During treatment and for 30 days following cessation of treatment
Number of Participants with Responses of Improved, Not Improved, and Worsened
Measured: After at least 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436578
- Sponsor's protocol ID
- P08547
- Other IDs
- MK-5592-091
- Status last verified
- Jul 2015
- First submitted
- 16 Sep 2011
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of NOXAFIL Oral Suspension in Usual Practice
- ClinicalTrials.gov ID
- NCT01436578
- Acronym / sponsor ID
- P08547
- Conditions
- Fungal Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Drug: Posaconazole oral suspension 40 mg/mLAll participants treated with posaconazole oral suspension during the pre-specified surveillance period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Treated with posaconazole oral suspension within current local label
Key exclusion criteria (1 listed)
- Contraindication to posaconazole oral suspension according to current local label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posaconazole oral suspension 40 mg/mLAlso: NOXAFILPosaconazole oral suspension prescribed according to the current local label | Drug | All Participants |
Primary outcome
Number of participants with Serious Adverse Experiences
Time frame: During treatment and for 30 days following cessation of treatment
Number of participants with drug-related adverse experiences
Time frame: During treatment and for 30 days following cessation of treatment
Number of participants with unexpected drug-related adverse experiences
Time frame: During treatment and for 30 days following cessation of treatment
Number of participants with Non-Serious Adverse Experiences
Time frame: During treatment and for 30 days following cessation of treatment
Number of Participants with Responses of Improved, Not Improved, and Worsened
Time frame: After at least 14 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Infections, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Serious Adverse Experiences (time frame: During treatment and for 30 days following cessation of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.