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Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790998
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Medicines Development for Global Health

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: Moxidectin Drug: Ivermectin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1497 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : April 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : May 2012

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. skin microfilaria density (mf/mg) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790998


Locations
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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
Medicines Development for Global Health
World Health Organization
Investigators
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Study Director: Special Programme for Research and Training in Tropical Diseases (TDR) World Health Organization
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Medicines Development for Global Health
ClinicalTrials.gov Identifier: NCT00790998    
Other Study ID Numbers: 3110A1-3000
B1751006 - ONCBL60801
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: November 2013
Keywords provided by Medicines Development for Global Health:
onchocerciasis
river blindness
onchocerca volvulus
moxidectin
ivermectin
Additional relevant MeSH terms:
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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