Study Evaluating Orally Administered Moxidectin in Subjects With Onchocerca Volvulus Infection - Full Text View

Purpose

The purpose of this study is to determine the safety, tolerability, efficacy and pharmacokinetics of orally administered moxidectin in subjects with onchocerca volvulus infection.

Condition	Intervention	Phase
Onchocerciasis	Drug: moxidectin Drug: ivermectin	Phase II

ChemIDplus related topics:

Ivermectin Moxidectin

U.S. FDA Resources

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

Official Title:	A Randomized, Single-Ascending Dose, Ivermectin-Controlled, Double-Blind, Safety, Tolerability, Pharmacokinetic, and Efficacy Study of Orally Administered Moxidectin in Subjects With Onchocerca Volvulus Infection

Further study details as provided by Wyeth:

Primary Outcome Measures:

Incidence of clinical adverse events and clinically significant laboratory test results [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Skin mf counts at day 8 and months 1, 2, 3, 6 and 12 [ Time Frame: day 8 and months 1, 2, 3, 6 and 12 ] [ Designated as safety issue: No ]
Nodulectomy at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12 [ Time Frame: days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	192
Study Start Date:	August 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: moxidectin Single-dose tablet
B: Active Comparator	Drug: ivermectin Single-dose tablet

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Otherwise healthy males and non-pregnant, non-breastfeeding females infected by onchocerca volvulus

Exclusion Criteria:

Administration of any medication or herbal preparation within 10 days prior to test article administration
Clinically significant electrocardiogram (ECG)
History of neurological or neuropsychiatric disease or epilepsy

Other exclusions apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300768

Locations


Ghana, Volta Region

	Hoehoe, Volta Region, Ghana

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:	3110A1-200
First Received:	March 7, 2006
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00300768
Health Authority:	Ghana: Ministry of Health

Keywords provided by Wyeth:

onchocerciasis

onchocerca volvulus

river blindness

ivermectin

moxidectin

onchocerca volvulus

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 August 28, 2008

Sponsors and Collaborators:	Wyeth World Health Organization
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00300768