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OpenTrials
Completed

NCT Number: NCT00790998

Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

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.

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Key information

Conditions

Onchocerciasis Eye Diseases Eye Infections Eye Infections, Parasitic Filariasis Helminthiasis Infections Nematode Infections Onchocerciasis, Ocular Parasitic Diseases Secernentea Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Spirurida Infections Vector Borne Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre de Recherche Clinique de Butembo - Université Catholique du Graben, Butembo, Democratic Republic of the Congo

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects with Onchocerca volvulus infection

Exclusion criteria

  • Pregnant or breast feeding women; coincidental loiasis

Treatment and study plan

Moxidectin

Drug

Single dose of moxidectin 2 mg oral tablet x 4

Ivermectin

Drug

Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4

Other names: Ivermectin, Mectizan, Stromectol

Primary outcomes

  1. skin microfilaria density (mf/mg)

    Time frame: 12 months

Secondary outcomes

  1. skin microfilaria density (mf/mg)

    Time frame: 1 month

  2. skin microfilaria density (mf/mg)

    Time frame: 6 months

  3. skin microfilaria density (mf/mg)

    Time frame: 18 months

  4. skin microfilaria reduction from baseline

    Time frame: 1 month

  5. skin microfilaria reduction from baseline

    Time frame: 6 months

  6. skin microfilaria reduction from baseline

    Time frame: 12 months

  7. skin microfilaria reduction from baseline

    Time frame: 18 months

  8. proportion of subjects with undetectable levels of skin microfilaria

    Time frame: 1 month

  9. proportion of subjects with undetectable levels of skin microfilaria

    Time frame: 6 months

  10. proportion of subjects with undetectable levels of skin microfilaria

    Time frame: 12 months

  11. proportion of subjects with undetectable levels of skin microfilaria

    Time frame: 18 months

  12. percent reduction in microfilaria levels in the anterior chamber of the eye

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medicines Development for Global Health

Other

Collaborators

  • World Health Organization

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 14, 2008
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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