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Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

This study has been completed.
Sponsor:
Information provided by:
World Health Organization
ClinicalTrials.gov Identifier:
NCT00790998
First received: November 13, 2008
Last updated: November 26, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 World Health Organization:

Primary Outcome Measures:
  • skin microfilaria density (mf/mg) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • skin microfilaria density (mf/mg) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • skin microfilaria density (mf/mg) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • skin microfilaria density (mf/mg) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • skin microfilaria reduction from baseline [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • skin microfilaria reduction from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • skin microfilaria reduction from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • skin microfilaria reduction from baseline [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • proportion of subjects with undetectable levels of skin microfilaria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • percent reduction in microfilaria levels in the anterior chamber of the eye [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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
Other Name: Moxidectin
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
Genders Eligible for Study:   Both
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

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:
No publications provided

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
Health Authority: Republic of Liberia: Ministry of Health and Social Welfare
Democratic Republic of the Congo: Ministry of Public Health
Ghana: Ghana Food and Drug Board

Keywords provided by World Health Organization:
onchocerciasis
river blindness
onchocerca volvulus
moxidectin
ivermectin

Additional relevant MeSH terms:
Onchocerciasis
Filariasis
Helminthiasis
Nematode Infections
Parasitic Diseases
Secernentea Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Spirurida Infections
Ivermectin
Milbemycin
Anthelmintics
Anti-Infective Agents
Antinematodal Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014