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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
November 13, 2008
November 14, 2008
November 17, 2017
April 2009
February 2012   (Final data collection date for primary outcome measure)
skin microfilaria density (mf/mg) [ Time Frame: 12 months ]
The primary endpoint is the skin microfilariae density (mf/mg) at 12 months after the administration of drug [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00790998 on ClinicalTrials.gov Archive Site
  • 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 ]
Skin microfilariae at additional time points; reduction from baseline; proportion of subjects with undetectable skin microfilariae; reduction in ocular microfilariae [ Time Frame: 18 months ]
Not Provided
Not Provided
 
Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection
A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Onchocerciasis
  • Drug: Moxidectin
    Single dose of moxidectin 2 mg oral tablet x 4
  • Drug: Ivermectin
    Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4
    Other Name: Ivermectin, Mectizan, Stromectol
  • Experimental: Moxidectin
    Moxidectin 8mg
    Intervention: Drug: Moxidectin
  • Active Comparator: Ivermectin
    Ivermectin 150 mcg/kg
    Intervention: Drug: Ivermectin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1497
May 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

  • Pregnant or breast feeding women; coincidental loiasis
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Congo, The Democratic Republic of the,   Ghana,   Liberia
Congo
 
NCT00790998
3110A1-3000
B1751006 - ONCBL60801
Yes
Not Provided
Not Provided
Medicines Development Limited
Medicines Development Limited
World Health Organization
Study Director: Special Programme for Research and Training in Tropical Diseases (TDR) World Health Organization
Medicines Development Limited
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP