Study Comparing Moxidectin and Ivermectin in Subjects With Onchocerca Volvulus Infection - Full Text View

Sponsors and Collaborators:	Wyeth 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

Drug Information available for: Ivermectin Moxidectin

U.S. FDA Resources

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

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

Sponsors and Collaborators

Wyeth

World Health Organization

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

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

Keywords provided by Wyeth:

onchocerciasis; river blindness; onchocerca volvulus
moxidectin; ivermectin

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Skin Diseases
Milbemycin
Gastrointestinal Diseases
Onchocerciasis
Intestinal Volvulus
Filariasis
Nematode Infections
Blindness

Intestinal Diseases
Intestinal Obstruction
Skin Diseases, Infectious
Digestive System Diseases
Ivermectin
Parasitic Diseases
Congenital Abnormalities
Helminthiasis

Additional relevant MeSH terms:

Anti-Infective Agents
Torsion Abnormality
Spirurida Infections
Antiparasitic Agents
Skin Diseases, Parasitic

Therapeutic Uses
Anthelmintics
Pharmacologic Actions
Antinematodal Agents
Secernentea Infections

ClinicalTrials.gov processed this record on January 16, 2009