Study Comparing Moxidectin and Ivermectin in Subjects With Onchocerca Volvulus Infection

This study is currently recruiting participants.

Verified by Wyeth, June 2009

First Received: November 13, 2008 Last Updated: June 9, 2009 History of Changes

Sponsor:	Wyeth
Collaborator:	World Health Organization
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00790998

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Ivermectin Moxidectin

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1500
Study Start Date:	December 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Moxidectin 8mg	Drug: Moxidectin
2: Active Comparator Ivermectin 150 mcg/kg	Drug: Ivermectin

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 Other exclusion criteria apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790998

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Liberia, Lofa County
	Recruiting
Bolahun, Lofa County, Liberia

Sponsors and Collaborators

Wyeth

World Health Organization

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3110A1-3000
Study First Received:	November 13, 2008
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00790998 History of Changes
Health Authority:	Ghana: Ministry of Health

Keywords provided by Wyeth:

onchocerciasis; river blindness; onchocerca volvulus
moxidectin; ivermectin

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Anti-Infective Agents
Skin Diseases, Parasitic
Gastrointestinal Diseases
Milbemycin
Intestinal Volvulus
Filariasis
Intestinal Obstruction
Torsion Abnormality
Antiparasitic Agents
Ivermectin
Therapeutic Uses
Parasitic Diseases

Helminthiasis
Antinematodal Agents
Skin Diseases
Onchocerciasis
Nematode Infections
Anthelmintics
Intestinal Diseases
Pharmacologic Actions
Spirurida Infections
Skin Diseases, Infectious
Digestive System Diseases
Secernentea Infections

ClinicalTrials.gov processed this record on November 27, 2009