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
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