Condition category
Not Applicable
Date applied
12/09/2005
Date assigned
01/02/2006
Last edited
24/11/2008
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

RPC117

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Received from the local medical ethics committee on the 27th May 2005

Study design

Single dose two-phase crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Pharmacokinetics of drug

Intervention

Two tablets of fixed dose artesunate and mefloquine, given once: total dose = AS 200mg, MQ 400 mg.

Loose tablets - 200 mg of artesunate (4 tablets) and 500 mg of mefloquine (2 tablets).

Intervention type

Drug

Phase

Not Specified

Drug names

Artesunate, mefloquine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

25/02/2005

Overall trial end date

25/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 to 50 years
2. Written consent given after reading the volunteer information leaflet. Participation must be voluntary and volunteers will be fully informed of possible side effects. They will be informed that they are free to withdraw at any time
3. No significant abnormal findings on history or examination, particularly no prior liver disease, cardiovascular disease (including arrythmias), peripheral neuropathy, convulsions, and psychiatric disease
4. No clinically significant abnormalities on:
4.1. Haematology:
4.1.1. Haemoglobin: male 13.6 - 17.5 g/dl, female 12 - 15.5 g/dl
4.1.2. Total white cell count: 4 - 10 x 10^3/ul
4.1.3. Platelet counts: 150 - 450 x 10^3/ul
4.2. Liver:
4.2.1. Total bilirubin less than 1.2 mg/dl
4.2.2. Serum Glutamic Oxaloacetic Transaminase (SGOT) less than or equal to 35 IU/l
4.2.3. Serum Glutamic Pyruvic Transaminase (SGPT) less than or equal to 35 IU/l
4.3. Renal function:
4.3.1. Creatinine 50 - 100 umol/l
4.3.2. Blood urea nitrogen 8 - 20 mg/dl
5. Negative pregnancy test (women) using the urine beta Human Chorionic Gonadotropin (βHCG)
6. Normal electrocardiogram (physicians reading: running at 50 mm/sec)
7. No history of antimalarial ingestion (chloroquine, amodiaquine, quinine, halofantrine, pyrimethamine-sulfadoxine) in the preceding two months, and for mefloquine, preceding three months
8. No other drugs or medications, including over-the counter preparations, ingested in the preceding week
9. Adequate venous access
10. Not participating in another clinical trial

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. Clinically significant physical signs detected by the examining physician
3. Abnormal electrocardiogram detected by the examining physician
4. Presence of hepatic, renal and gastrointestinal disorders
5. Smokers (greater than 10 cigarettes/day), abuse of alcohol or recreational drugs
6. Presence of malaria parasites on a thick smear
7. Subjects having been in a malarial area in the preceding eight weeks
8. Subjects having ingested drugs in the preceding week
9. Presence of acute or chronic infections
10. Allergy to study drugs

Recruitment start date

25/02/2005

Recruitment end date

25/02/2006

Locations

Countries of recruitment

Thailand

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

Confirming the International Role of Community Research for Development - Developing Countries (INCO-DEV)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Commission (ref: ICA4-2001-10193)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

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

Publication citations

Additional files

Editorial Notes