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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: March 15, 2013
Last verified: March 2013
History of Changes

November 13, 2008
March 15, 2013
April 2009
December 2011   (final data collection date for primary outcome measure)
skin microfilaria density (mf/mg) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary endpoint is the skin microfilariae density (mf/mg) at 12 months after the administration of drug [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00790998 on ClinicalTrials.gov Archive Site
  • 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 ]
Skin microfilariae at additional time points; reduction from baseline; proportion of subjects with undetectable skin microfilariae; reduction in ocular microfilariae [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Onchocerciasis
  • Drug: Moxidectin
    Single dose of moxidectin 2 mg oral tablet x 4
    Other Name: Moxidectin
  • Drug: Ivermectin
    Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4
    Other Name: Ivermectin, Mectizan, Stromectol
  • Experimental: 1
    Moxidectin 8mg
    Intervention: Drug: Moxidectin
  • Active Comparator: 2
    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
April 2012
December 2011   (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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Congo, The Democratic Republic of the,   Ghana,   Liberia
 
NCT00790998
3110A1-3000, B1751006 - ONCBL60801
Yes
Not Provided
World Health Organization
Not Provided
Study Director: Special Programme for Research and Training in Tropical Diseases (TDR) World Health Organization
World Health Organization
March 2013

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