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Study Evaluating Orally Administered Moxidectin in Subjects With Onchocerca Volvulus Infection

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Wyeth
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

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




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