Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Medicines Development for Global Health

Status and phase: Completed; Phase 3

Conditions: Onchocerciasis

Treatments: Drug: Ivermectin; Drug: Moxidectin

Study type: Interventional

Funder types: Other

Identifiers

NCT00790998

B1751006 - ONCBL60801

3110A1-3000

Details and patient eligibility

About

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.

Enrollment: 1,497 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects with Onchocerca volvulus infection

Exclusion criteria

• Pregnant or breast feeding women; coincidental loiasis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,497 participants in 2 patient groups

Moxidectin

Experimental group

Description:

Moxidectin 8mg

Treatment:

Drug: Moxidectin

Ivermectin

Active Comparator group

Description:

Ivermectin 150 mcg/kg

Treatment:

Drug: Ivermectin