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Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection
This study has been completed.
Sponsor:
World Health Organization
Information provided by:
World Health Organization
ClinicalTrials.gov Identifier:
NCT00790998
First received: November 13, 2008
Last updated: November 26, 2013
Last verified: November 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Onchocerciasis | Drug: Moxidectin Drug: Ivermectin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Onchocerciasis
Lymphatic Filariasis
Helminthiasis
U.S. FDA Resources
Further study details as provided by World Health Organization:
Primary Outcome Measures:
- skin microfilaria density (mf/mg) [ Time Frame: 12 months ]
Secondary Outcome Measures:
- skin microfilaria density (mf/mg) [ Time Frame: 1 month ]
- skin microfilaria density (mf/mg) [ Time Frame: 6 months ]
- skin microfilaria density (mf/mg) [ Time Frame: 18 months ]
- skin microfilaria reduction from baseline [ Time Frame: 1 month ]
- skin microfilaria reduction from baseline [ Time Frame: 6 months ]
- skin microfilaria reduction from baseline [ Time Frame: 12 months ]
- skin microfilaria reduction from baseline [ Time Frame: 18 months ]
- proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 1 month ]
- proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 6 months ]
- proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 12 months ]
- proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 18 months ]
- percent reduction in microfilaria levels in the anterior chamber of the eye [ Time Frame: 12 months ]
| Enrollment: | 1497 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Moxidectin
Moxidectin 8mg
|
Drug: Moxidectin
Single dose of moxidectin 2 mg oral tablet x 4
|
|
Active Comparator: Ivermectin
Ivermectin 150 mcg/kg
|
Drug: Ivermectin
Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4
Other Name: Ivermectin, Mectizan, Stromectol
|
Eligibility| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects with Onchocerca volvulus infection
Exclusion Criteria:
- Pregnant or breast feeding women; coincidental loiasis
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790998
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790998
Locations
| Congo, The Democratic Republic of the | |
| 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 | |
| Ghana | |
| Onchocerciasis Chemotherapy Research Center | |
| Hohoe, Ghana | |
| Liberia | |
| Liberian Institute for Biomedical Research Clinical Research Center | |
| Bolahun, Lofa County, Liberia | |
Sponsors and Collaborators
World Health Organization
Investigators
| Study Director: | Special Programme for Research and Training in Tropical Diseases (TDR) | World Health Organization |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00790998 History of Changes |
| Other Study ID Numbers: |
3110A1-3000 B1751006 - ONCBL60801 |
| Study First Received: | November 13, 2008 |
| Last Updated: | November 26, 2013 |
Keywords provided by World Health Organization:
|
onchocerciasis river blindness onchocerca volvulus moxidectin ivermectin |
Additional relevant MeSH terms:
|
Onchocerciasis Intestinal Volvulus Filariasis Spirurida Infections Secernentea Infections Nematode Infections Helminthiasis Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Intestinal Obstruction |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Torsion Abnormality Pathological Conditions, Anatomical Ivermectin Milbemycin Antiparasitic Agents Anti-Infective Agents Anthelmintics Antinematodal Agents |
ClinicalTrials.gov processed this record on July 17, 2017