Last updated: 08/14/2020 18:00:10
Drug Use Investigation for MALARONE Combination Tablets - Investigation on Malaria (Treatment and Prevention)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2014-31-01
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)
No location data available.
Study documents
Protocol
Available language(s): English
Clinical study report
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
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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