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

Sponsor:	Wyeth
Collaborator:	World Health Organization
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00300768

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

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

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:

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

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3110A1-200
Study First Received:	March 7, 2006
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00300768 History of Changes
Health Authority:	Ghana: Ministry of Health

Keywords provided by Wyeth:

onchocerciasis
onchocerca volvulus
river blindness

ivermectin
moxidectin
onchocerca volvulus

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Anti-Infective Agents
Skin Diseases, Parasitic
Gastrointestinal Diseases
Milbemycin
Intestinal Volvulus
Filariasis
Infection
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 09, 2009