Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs

NCT01065116 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 920

Last updated 2011-07-21

No results posted yet for this study

Summary

The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.

Conditions

Interventions

DRUG

AL Blister-packs with Instruction leaflets

AL Blister packs with instruction leaflets will be dispensed

DRUG

AL unit dose age specific pre-packs

Age specific colour coded Unit dose pre-packs will be used

Sponsors & Collaborators

  • Ministry of Health, Uganda

    collaborator OTHER_GOV
  • Makerere University

    collaborator OTHER
  • Malaria Consortium, Uganda

    lead OTHER

Principal Investigators

  • Joaniter I Nankabirwa, MSc CEB · Makerere University Kampala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Uganda

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Entities

Diseases

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 NCT01065116 on ClinicalTrials.gov