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Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00790998
First Posted: November 14, 2008
Last Update Posted: November 17, 2017
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.
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Medicines Development Limited
  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: 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

Resource links provided by NLM:


Further study details as provided by Medicines Development Limited:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
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 Limited
World Health Organization
Investigators
Study Director: Special Programme for Research and Training in Tropical Diseases (TDR) World Health Organization
  More Information

Responsible Party: Medicines Development Limited
ClinicalTrials.gov Identifier: NCT00790998     History of Changes
Other Study ID Numbers: 3110A1-3000
B1751006 - ONCBL60801
First Submitted: November 13, 2008
First Posted: November 14, 2008
Last Update Posted: November 17, 2017
Last Verified: November 2013

Keywords provided by Medicines Development Limited:
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