Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

This study has been completed.

First Received on March 7, 2006. Last Updated on September 20, 2010 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:	World Health Organization
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 is now a wholly owned subsidiary of Pfizer:

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 ]

Enrollment:	172
Study Start Date:	September 2006
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Dose-escalating experimental arm (moxidectin 2mg, 4mg or 8mg)	Drug: moxidectin Single-dose tablet
Active Comparator: B Active comparator arm (ivermectin 150 mcg/kg).	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
Pfizer Investigational Site
Hoehoe, Volta Region, Ghana

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

World Health Organization

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00300768 History of Changes
Other Study ID Numbers:	3110A1-200, B1751004
Study First Received:	March 7, 2006
Last Updated:	September 20, 2010
Health Authority:	Ghana : Food and Drugs Board

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

onchocerciasis
onchocerca volvulus
river blindness
ivermectin
moxidectin

Additional relevant MeSH terms:

Onchocerciasis
Intestinal Volvulus
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Intestinal Obstruction
Intestinal Diseases

Gastrointestinal Diseases
Digestive System Diseases
Torsion Abnormality
Pathological Conditions, Anatomical
Ivermectin
Milbemycin
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anthelmintics
Antinematodal Agents

ClinicalTrials.gov processed this record on February 09, 2012