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Efficacy of ArTiMist™ in Children

NCT01047436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-01-27

Study results available
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Summary

The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.

Conditions

  • Falciparum Malaria

Interventions

DRUG

Quinine

20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy

DRUG

Artemether

Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy

Sponsors & Collaborators

  • Xidea Solutions Limited

    collaborator UNKNOWN

  • Proto Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Daryl Bendel, MBChB MBA Dip Pharm Med MFPM · Xidea Solutions Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-01-31
Completion
2010-01-31

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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 NCT01047436 on ClinicalTrials.gov