Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Sponsor

Medicines Development for Global Health (Other)

Overall Status

Completed

CT.gov ID

NCT00790998

Collaborator

World Health Organization (Other)

1,497

Enrollment

Locations

Arms

Duration (Months)

374.3

Patients Per Site

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Onchocerciasis	Drug: Moxidectin Drug: Ivermectin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1497 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

skin microfilaria density (mf/mg) [12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

Pregnant or breast feeding women; coincidental loiasis

Contacts and Locations

Locations

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