Last updated: 02/03/2020 22:00:17

Drug Use Investigation of SAMTIREL (atovaquone) Oral Suspension 15%

GSK study ID
116460
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Use Investigation of SAMTIREL (atovaquone) Oral Suspension 15%
Trial description: The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of atovaquone oral suspension in Japanese patients with pneumocystis pneumonia (PCP) or in patients who are at risk of developing PCP.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse drug reaction by patients' backgrounds

Timeframe: For a maximum of 21 days for PCP treatment and for a maximum of 1 year for PCP prophylaxis

Presence or absence of skin disorder

Timeframe: For a maximum of 21 days for PCP treatment and for a maximum of 1 year for PCP prophylaxis

Efficacy of treatment

Timeframe: For a maximum of 21 days for PCP treatment and for a maximum of 1 year for PCP prophylaxis

Presence or absence of hepatic function abnormal

Timeframe: For a maximum of 21 days for PCP treatment and for a maximum of 1 year for PCP prophylaxis

Presence or absence of gastrointestinal disorder

Timeframe: For a maximum of 21 days for PCP treatment and for a maximum of 1 year for PCP prophylaxis

Prophylactic efficacy

Timeframe: For a maximum of 21 days for PCP treatment and for a maximum of 1 year for PCP prophylaxis

Secondary outcomes:
Not applicable
Interventions:
Drug: Atovaquone oral suspension
Enrollment:
500
Observational study model:
Other
Primary completion date:
2019-16-01
Time perspective:
Other
Clinical publications:
Yuna Onaka, Rika Tanaka, Kenji Oda, Terufumi Hara, Wataru Sugiura. The Safety and Efficacy of Atovaquone in Patients with Pneumocystis Pneumonia- The Results of a Drug Use Investigation. Ther Res. 2020;40(9):719-44
Medical condition
Pneumonia, Pneumocystis carinii
Product
atovaquone
Collaborators
Not applicable
Study date(s)
July 2012 to January 2019
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
  • Atovaquone oral suspension must be administered for the first time
  • Patients with PCP or patients who are at risk of developing PCP
  • Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
  • Atovaquone oral suspension must be administered for the first time
  • Patients with PCP or patients who are at risk of developing PCP
Exclusion criteria:
  • Not applicable

Trial location(s)

No location data available.

Study documents

Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2019-16-01
Actual study completion date
2019-16-01

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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