Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

January 29, 2018 updated by: Medicines Development for Global Health

A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus

This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1497

Phase

  • Phase 3

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

  • Congo, The Democratic Republic of the
      • Butembo, Congo, The Democratic Republic of the
        • Centre de Recherche Clinique de Butembo - Université Catholique du Graben
      • Rethy, Congo, The Democratic Republic of the
        • Centre de Recherche en Maladies Tropicales de l'Ituri
  • Ghana
      • Hohoe, Ghana
        • Onchocerciasis Chemotherapy Research Center
  • Liberia
    • Lofa County
      • Bolahun, Lofa County, Liberia
        • Liberian Institute for Biomedical Research Clinical Research Center

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

  • Pregnant or breast feeding women; coincidental loiasis

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moxidectin
Moxidectin 8mg
Drug: Moxidectin
Single dose of moxidectin 2 mg oral tablet x 4
Active Comparator: Ivermectin
Ivermectin 150 mcg/kg
Drug: Ivermectin
Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4
Other Names:
  • Ivermectin, Mectizan, Stromectol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
skin microfilaria density (mf/mg)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
skin microfilaria density (mf/mg)
Time Frame: 1 month
1 month
skin microfilaria density (mf/mg)
Time Frame: 6 months
6 months
skin microfilaria density (mf/mg)
Time Frame: 18 months
18 months
skin microfilaria reduction from baseline
Time Frame: 1 month
1 month
skin microfilaria reduction from baseline
Time Frame: 6 months
6 months
skin microfilaria reduction from baseline
Time Frame: 12 months
12 months
skin microfilaria reduction from baseline
Time Frame: 18 months
18 months
proportion of subjects with undetectable levels of skin microfilaria
Time Frame: 1 month
1 month
proportion of subjects with undetectable levels of skin microfilaria
Time Frame: 6 months
6 months
proportion of subjects with undetectable levels of skin microfilaria
Time Frame: 12 months
12 months
proportion of subjects with undetectable levels of skin microfilaria
Time Frame: 18 months
18 months
percent reduction in microfilaria levels in the anterior chamber of the eye
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Medicines Development for Global Health

Collaborators

World Health Organization

Investigators

  • Study Director: Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization

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

Helpful Links

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

April 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3110A1-3000
  • B1751006 - ONCBL60801

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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