Status:
COMPLETED
RBx11160 Phase II Dose Ranging Study RBx/MMV05-06
Lead Sponsor:
Medicines for Malaria Venture
Collaborating Sponsors:
Ranbaxy Laboratories Limited
Swiss Tropical & Public Health Institute
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
13-65 years
Phase:
PHASE2
Brief Summary
The trial will identify the best dose of the synthetic peroxide RBx11160 to treat uncomplicated malaria. Patients will be treated over 7 days with daily doses of 50, 100 or 200 mg RBx11160. The study...
Detailed Description
This is a Phase II, double-blind, multicenter, randomized, parallel-group, dose-ranging study of the antimalarial activity and safety of 3 (50, 100, and 200 mg) RBx 11160 dose levels administered as a...
Eligibility Criteria
Inclusion
- Male or female patients aged 13 to 65 years, inclusive.
- Body weight \> 30 kg with no clinical evidence of severe malnutrition.
- Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum parasites only. Initial parasite densities appropriate for inclusion will be between 1000 and 100,000 asexual parasites/microL blood.
- Presence of fever (axillary temperature \> 37.5 °C or oral or rectal temperature \> 38 °C).
- Female patients must be non-lactating and willing to use contraceptive methods during the study period.
- Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If a patient is unable to provide informed consent in writing, a thumbprint to indicate consent in the presence of at least 1 witness is acceptable. If applicable, for adolescents providing written informed consent, assent should be obtained from the patient's legally accepted representative/guardian.
- Willingness and ability to comply with the study protocol for the duration of the study.
- Patient resides within a reasonable distance of the investigational site, so that attendance of all study visits and follow-up by medical staff are logistically feasible.
Exclusion
- Patients presenting with a mixed infection (i.e., malaria due to more than 1 causative parasite).
- Patients with severe malaria.
- Any antimalarial treatment during 2 weeks prior to Screening, as assessed by medical history.
- History of hypersensitivity or allergic reactions to artemisinins.
- Patients who have been treated with RBx 11160 in any study.
- Participation in any investigational drug study during the 30 days prior to Screening.
- Electrocardiogram (ECG) abnormalities with clinical significance or relevance that require urgent management. These abnormalities include QTc interval \> 450 msec at Screening and cardiac conduction disorders, with the exception of right bundle branch block.
- A female patient who is lactating or pregnant at Screening.
- Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhea defined as \> 3 episodes of watery stools in the previous 24 hours or patients who have had 3 episodes of vomiting within 24 hours prior to Screening).
- Patients with known significant renal or hepatic impairment indicated by the following laboratory evaluations at Screening:
- Serum creatinine \> 1.5 x upper limit of normal (ULN). Aspartate transaminase \> 2.5 x ULN. Alanine transaminase \> 2.5 x ULN. Alkaline phosphatase \> 2.5 x ULN. Total bilirubin \> 1.5 x ULN.
- Patients who have had a splenectomy.
- Immunocompromised patients, patients receiving immunosuppressive agents, or patients with known human immunodeficiency virus (HIV) infection. (Screening for these conditions is not required for entry in the study.)
- Evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric (e.g., depression, anxiety, psychosis, or schizophrenia) or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).
- Patients who have epilepsy or a history of convulsions.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00362050
Start Date
June 1 2006
End Date
January 1 2007
Last Update
August 29 2007
Active Locations (4)
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1
Field Station Malaria Reseach Centre (Indian Council of Medical Research)
Rourkela, Odisha, India, 769 002
2
Public Health Care Center
Kivunge, Zanzibar, Tanzania
3
District Hospital Bagamayo
Dar es Salaam, Tanzania
4
Faculty of Tropical Medicine, 420/6 Rajavithee Road
Bangkok, Thailand, 10400