Last updated: 08/26/2021 05:10:08

MALARONE Pediatric Combination Tablets Special Drug Use Investigation

GSK study ID
205654
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: MALARONE Pediatric Combination Tablets Special Drug Use Investigation
Trial description: This post-marketing surveillance (PMS) study is conducted to collect data on safety and effectiveness in pediatric subjects receiving atovaquone and proguanil for the treatment or prophylaxis of malaria in daily clinical practice. MALARONE is a registered trademark of the GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The 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:
    30
    Primary completion date:
    2020-31-07
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Yasuyo Nose, Shigeomi Iimura, Eri Sasaki, Kiyomi Aizawa, Daisaku Yasui, Naohiro Takahashi.Assessment of the Safety and Effectiveness of Atovaquone/Proguanil Hydrochloride Tablets (Malarone Pediatric Combination Tablets) in Daily Clinical Practice When Used for Treatment or Prevention of Malaria in Children - Report of the Results of Special Drug Use Investigation.Prog Med.2021;41:671-679
    Medical condition
    Malaria
    Product
    atovaquone, atovaquone/proguanil, proguanil
    Collaborators
    Not applicable
    Study date(s)
    November 2016 to July 2020
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 14 Years
    Accepts healthy volunteers
    Not applicable
    • Pediatric subjects with malaria or healthy subjects
    • Pediatric subjects receiving atovaquone and proguanil for the first time
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Pediatric subjects with malaria or healthy subjects
    • Pediatric subjects receiving atovaquone and proguanil for the first time
    • Pediatric subjects 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

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    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
    2020-31-07
    Actual study completion date
    2020-31-07

    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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