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

Tracking Information

First Received Date ^ICMJE

March 7, 2006

Last Updated Date

July 17, 2008

Start Date ^ICMJE

August 2006

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Incidence of clinical adverse events and clinically significant laboratory test results

Change History

Complete list of historical versions of study NCT00300768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Skin mf counts at day 8 and months 1, 2, 3, 6 and 12
Nodulectomy at 18 months
PK at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Orally Administered Moxidectin in Subjects With Onchocerca Volvulus Infection

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Onchocerciasis

Intervention ^ICMJE

Drug: moxidectin
Drug: ivermectin

Study Arms / Comparison Groups

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

Active, not recruiting

Estimated Enrollment ^ICMJE

192

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Ghana

Administrative Information

NCT ID ^ICMJE

NCT00300768

Responsible Party

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

Study ID Numbers ^ICMJE

3110A1-200

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

World Health Organization

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

July 2008

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