Last updated: 08/26/2021 05:10:08
MALARONE Pediatric Combination Tablets Special Drug Use Investigation
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Only
Primary completion date:
2020-31-07
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
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
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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