Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

January 14, 2010 updated by: DBL -Institute for Health Research and Development

Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Study on Trichuris Trichiura.

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Vector Control Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those who are enrolled in class one to six
  • Are infected with T. trichiura
  • Whose parent consent and who are willing to participate

Exclusion Criteria:

  • Those with acute and chronic diseases other than T. trichiura
  • Those with a history of any serious adverse drug reactions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
albendazole treatment
Drug: albendazole
albendazole (400 mg on dose)
Active Comparator: 2
mebendazole treatment
Drug: mebendazole
mebendazole (500 mg one dose)
Active Comparator: 3
ivermectin treatment
Drug: ivermectin
ivermectin (200 microgram/kg body weight)
Active Comparator: 4
albendazole + ivermectin treatment
Drug: albendazole + ivermectin
albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)
Active Comparator: 5
mebendazole + ivermectin treatment
Drug: mebendazole + ivermectin
mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Record adverse reactions
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of treatment
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DBL -Institute for Health Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AO.UGA.TRI
  • DBL-CHRD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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