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
Study complete
Study complete
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
    Primary completion date:
    2019-16-01
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    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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