Condition category
Infections and Infestations
Date applied
15/04/2005
Date assigned
07/06/2005
Last edited
28/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr W Taylor

ORCID ID

Contact details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland
-
taylorw@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC112

Study information

Scientific title

Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination (Malaysia)

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Malaria

Intervention

Artesunate tablet 50 mg. Amodiaquine tablet (153 mg base/tablet).
Combination of artesunate/amodiaquine (100 mg and 270 mg, respectively).
For both arms, a single dose of appropriate drug(s) will be taken orally with 200 ml tap water after an overnight fast.

Intervention type

Drug

Phase

Not Applicable

Drug names

Artesunate, amodiaquine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

26/11/2004

Overall trial end date

26/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male/female age 21 - 45 years
2. Written consent
3. Voluntary participation fully aware of possible side effects
4. No significant abnormal findings on history or examination, particularly no prior liver disease, cardiovascular disease or peripheral neuropathy
5. No clinically significant abnormalities on haematology, liver and renal function tests
6. Non pregnant on test (women)
7. Normal electrocardiogram (ECG)
8. No history of antimalarial ingestion (chloroquine, amodiaquine, quinine, halofantrine, pyrimethamine-sulfadoxine associated or not to mefloquine) in the preceding two months
9. No other drugs or medications, including over-the-counter preparations, ingested in the preceding week
10. Adequate venous access

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Refusal of consent
2. Biological or electrocardiographic anomalies
3. Presence of hepatic, renal and gastrointestinal disorders
4. Smokers (>10/day), abuse of alcohol or recreational drugs
5. Presence of malaria parasites on a thick smear
6. Subjects having been in a malarial area in the preceding 8 weeks
7. Subjects having ingested drugs in the preceding week
8. Presence of acute or chronic infections

Recruitment start date

26/11/2004

Recruitment end date

26/11/2006

Locations

Countries of recruitment

Malaysia

Trial participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Sponsor details

15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland
+41 (0)22 906 9230
dndi@dndi.org

Sponsor type

Research organisation

Website

http://www.dndi.org

Funders

Funder type

Research organisation

Funder name

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Commission

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19404632

Publication citations

Additional files

Editorial Notes

28/03/2017: Publication reference added.