Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

NCT ID: NCT00790998

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1497 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Onchocerciasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Moxidectin

Moxidectin 8mg

Group Type EXPERIMENTAL

Moxidectin

Intervention Type DRUG

Single dose of moxidectin 2 mg oral tablet x 4

Ivermectin

Ivermectin 150 mcg/kg

Group Type ACTIVE_COMPARATOR

Ivermectin

Intervention Type DRUG

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

Interventions

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Moxidectin

Single dose of moxidectin 2 mg oral tablet x 4

Intervention Type DRUG

Ivermectin

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

Intervention Type DRUG

Other Intervention Names

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Ivermectin, Mectizan, Stromectol

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria

* Pregnant or breast feeding women; coincidental loiasis
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

Medicines Development for Global Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

World Health Organization

Locations

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Centre de Recherche Clinique de Butembo - Université Catholique du Graben

Butembo, , Democratic Republic of the Congo

Site Status

Centre de Recherche en Maladies Tropicales de l'Ituri

Rethy, , Democratic Republic of the Congo

Site Status

Onchocerciasis Chemotherapy Research Center

Hohoe, , Ghana

Site Status

Liberian Institute for Biomedical Research Clinical Research Center

Bolahun, Lofa County, Liberia

Site Status

Countries

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Democratic Republic of the Congo Ghana Liberia

References

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Opoku NO, Bakajika DK, Kanza EM, Howard H, Mambandu GL, Nyathirombo A, Nigo MM, Kasonia K, Masembe SL, Mumbere M, Kataliko K, Larbelee JP, Kpawor M, Bolay KM, Bolay F, Asare S, Attah SK, Olipoh G, Vaillant M, Halleux CM, Kuesel AC. Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial. Lancet. 2018 Oct 6;392(10154):1207-1216. doi: 10.1016/S0140-6736(17)32844-1. Epub 2018 Jan 18.

Reference Type RESULT
PMID: 29361335 (View on PubMed)

Bakajika D, Kanza EM, Opoku NO, Howard HM, Mambandu GL, Nyathirombo A, Nigo MM, Kennedy KK, Masembe SL, Mumbere M, Kataliko K, Bolay KM, Attah SK, Olipoh G, Asare S, Vaillant M, Halleux CM, Kuesel AC. Effect of a single dose of 8 mg moxidectin or 150 mug/kg ivermectin on O. volvulus skin microfilariae in a randomized trial: Differences between areas in the Democratic Republic of the Congo, Liberia and Ghana and impact of intensity of infection. PLoS Negl Trop Dis. 2022 Apr 27;16(4):e0010079. doi: 10.1371/journal.pntd.0010079. eCollection 2022 Apr.

Reference Type DERIVED
PMID: 35476631 (View on PubMed)

Related Links

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http://dx.doi.org/10.1016/S0140-6736(17)32844-1

Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial

Other Identifiers

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B1751006 - ONCBL60801

Identifier Type: -

Identifier Source: secondary_id

3110A1-3000

Identifier Type: -

Identifier Source: org_study_id

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