Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection - Full Text View

Sponsor:	World Health Organization
Information provided by:	World Health Organization
ClinicalTrials.gov Identifier:	NCT00790998

Purpose

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.

Condition	Intervention	Phase
Onchocerciasis	Drug: Moxidectin Drug: Ivermectin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus

Resource links provided by NLM:

Drug Information available for: Ivermectin Moxidectin

U.S. FDA Resources

Further study details as provided by World Health Organization:

Primary Outcome Measures:

skin microfilaria density (mf/mg) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

skin microfilaria density (mf/mg) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
skin microfilaria density (mf/mg) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
skin microfilaria density (mf/mg) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
skin microfilaria reduction from baseline [ Time Frame: 1 month ] [ Designated as safety issue: No ]
skin microfilaria reduction from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
skin microfilaria reduction from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
skin microfilaria reduction from baseline [ Time Frame: 18 months ] [ Designated as safety issue: No ]
proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 1 month ] [ Designated as safety issue: No ]
proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
percent reduction in microfilaria levels in the anterior chamber of the eye [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	1497
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Moxidectin 8mg	Drug: Moxidectin Single dose of moxidectin 2 mg oral tablet x 4 Other Name: Moxidectin
Active Comparator: 2 Ivermectin 150 mcg/kg	Drug: Ivermectin Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4 Other Name: Ivermectin, Mectizan, Stromectol

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

Pregnant or breast feeding women; coincidental loiasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790998

Locations

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

Sponsors and Collaborators

World Health Organization

Investigators

Study Director:

Special Programme for Research and Training in Tropical Diseases (TDR)

World Health Organization

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00790998 History of Changes
Other Study ID Numbers:	3110A1-3000, B1751006 - ONCBL60801
Study First Received:	November 13, 2008
Last Updated:	October 7, 2011
Health Authority:	Republic of Liberia: Ministry of Health and Social Welfare; Democratic Republic of the Congo: Ministry of Public Health; Ghana: Ghana Food and Drug Board

Keywords provided by World Health Organization:

onchocerciasis
river blindness
onchocerca volvulus
moxidectin
ivermectin

Additional relevant MeSH terms:

Onchocerciasis
Intestinal Volvulus
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Intestinal Obstruction
Intestinal Diseases

Gastrointestinal Diseases
Digestive System Diseases
Torsion Abnormality
Pathological Conditions, Anatomical
Ivermectin
Milbemycin
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anthelmintics
Antinematodal Agents

ClinicalTrials.gov processed this record on February 12, 2012