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RBx11160 Phase II Dose Ranging Study RBx/MMV05-06

NCT00362050 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2007-08-29

No results posted yet for this study

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 is designed to assess the antimalarial activity and safety of 3 dose levels of RBx 11160 administered once daily for 7 consecutive days. The primary endpoint will be the time to 90% parasite clearance. In future regulatory studies, RBx 11160 is likely to be administered in combination with another antimalarial agent since the development plan follows the current recommendation of WHO for the treatment of uncomplicated malaria. However, it is critical to gather data on RBx 11160 when used as monotherapy in adult patients suffering from acute uncomplicated P. falciparum malaria. In malaria-endemic regions, an adult population is defined on the basis of immune status rather than the legal age of consent. Thus, patients as young as 13 years of age can be enrolled provided consent has been obtained from a legal guardian in accordance with local practices and regulations. This study will be conducted in compliance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP).

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

Treatment with 3 dose groups of RBx11160 over 7 days

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    collaborator INDUSTRY

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Sornchai Looareesuwan, MD · Mahidol University

  • Salim M Abdulla, MD · District Hospital Bagamoyo, Dar es Salaam, Tanzania

  • Anders Björkman, MD · Kivunge Public Health Care Center, Zanzibar, Tanzania

  • Neena Valecha, MD · Malaria Research Center, Rourkela, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Completion
2007-01-31

Countries

  • India
  • Tanzania
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00362050 on ClinicalTrials.gov