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

Tracking Information

First Received Date ^ICMJE

November 13, 2008

Last Updated Date

June 9, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00790998 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Comparing Moxidectin and Ivermectin in Subjects With Onchocerca Volvulus Infection

Official Title ^ICMJE

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 Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Onchocerciasis

Intervention ^ICMJE

Drug: Moxidectin
Drug: Ivermectin

Study Arms / Comparison Groups

1: Experimental
Moxidectin 8mg

Intervention: Drug: Moxidectin
2: Active Comparator
Ivermectin 150 mcg/kg

Intervention: Drug: Ivermectin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1500

Estimated Completion Date

August 2010

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Male and female subjects with Onchocerca volvulus infection

Exclusion criteria:

Pregnant or breast feeding women; coincidental loiasis Other exclusion criteria apply

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Trial Manager

clintrialparticipation@wyeth.com

Location Countries ^ICMJE

Liberia

Administrative Information

NCT ID ^ICMJE

NCT00790998

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study ID Numbers ^ICMJE

3110A1-3000

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

World Health Organization

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

June 2009

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