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Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Information source: World Health Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Onchocerciasis

Intervention: Moxidectin (Drug); Ivermectin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: World Health Organization

Official(s) and/or principal investigator(s):
Special Programme for Research and Training in Tropical Diseases (TDR), Study Director, Affiliation: World Health Organization

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: skin microfilaria density (mf/mg)

Secondary outcome:

skin microfilaria density (mf/mg)

skin microfilaria density (mf/mg)

skin microfilaria density (mf/mg)

skin microfilaria reduction from baseline

skin microfilaria reduction from baseline

skin microfilaria reduction from baseline

skin microfilaria reduction from baseline

proportion of subjects with undetectable levels of skin microfilaria

proportion of subjects with undetectable levels of skin microfilaria

proportion of subjects with undetectable levels of skin microfilaria

proportion of subjects with undetectable levels of skin microfilaria

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

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

- Pregnant or breast feeding women; coincidental loiasis

Locations and Contacts

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

Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana

Liberian Institute for Biomedical Research Clinical Research Center, Bolahun, Lofa County, Liberia

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2009
Last updated: November 26, 2013

Page last updated: August 23, 2015

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