Clinical Trial: Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus

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.

Detailed Summary:
Sponsor: World Health Organization

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

Original Primary Outcome: The primary endpoint is the skin microfilariae density (mf/mg) at 12 months after the administration of drug [ Time Frame: 12 months ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Skin microfilariae at additional time points; reduction from baseline; proportion of subjects with undetectable skin microfilariae; reduction in ocular microfilariae [ Time Frame: 18 months ]

Information By: World Health Organization

Dates:
Date Received: November 13, 2008
Date Started: April 2009
Date Completion:
Last Updated: November 26, 2013
Last Verified: November 2013