Last updated: 08/14/2020 18:00:10

Drug Use Investigation for MALARONE Combination Tablets - Investigation on Malaria (Treatment and Prevention)

GSK study ID
116932
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 for MALARONE Combination Tablets - Investigation on Malaria (Treatment and Prevention)
Trial description: This post-marketing surveillance (PMS) study is conducted to collect data on safety and effectiveness in subjects receiving atovaquone and proguanil for the treatment or prophylaxis of malaria.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence of adverse drug reactions

Timeframe: 21 days for the treatment of malaria and 3 months for the prophylaxis of malaria

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Atovaquone and proguanil hydrochloride
    • Enrollment:
    1418
    Primary completion date:
    2014-31-01
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Rie Otake, Tomohiko Takahashi, Kiyomi Aizawa, Takeshi Ebihara, Terufumi Hara, Pascal Yoshida. Evaluation of the safety and efficacy of atovaquone/proguanil hydrochloride tablets (Malarone® Combination Tablets) in clinical practice in Japanfor the treatment or prevention of malaria - Final report of drug use investigation -. J Clin Therapeut Med. 2018;34(7).
    Medical condition
    Malaria
    Product
    atovaquone, atovaquone/proguanil, proguanil
    Collaborators
    Not applicable
    Study date(s)
    April 2013 to June 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    None
    • Subjects with malaria or healthy subjects
    • Subject receiving atovaquone and proguanil for the treatment or prophylaxis of malaria
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with malaria or healthy subjects
    • Subject receiving atovaquone and proguanil for the treatment or prophylaxis of malaria
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2014-31-01
    Actual study completion date
    2017-05-06

    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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