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Pediatric Pharmacokinetics And Safety Study Of Moxidectin

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NCT01035619

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Onchocerciasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-11 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects aged 4 to 11 years, inclusive (weighing >= 12 kg)

- With or without O volvulus infection

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any major illness/condition that, in the investigator's judgment, will substantially
increase the risk associated with the subject's participation in and completion of the
study

- Contraindication or hypersensitivity to moxidectin

NCT01035619
Pfizer
Withdrawn
Pediatric Pharmacokinetics And Safety Study Of Moxidectin

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Similar Trials

Onchocerciasis
Pediatric Pharmacokinetics And Safety Study Of Moxidectin
NCT01035619
All Genders
Pediatric Pharmacokinetics And Safety Study Of Moxidectin
A Single-Center, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety, And Tolerability Of Moxidectin In Subjects Aged 4 To 11 Years ( >=12 kg) With Or Without Onchocerca Volvulus Infection
The purpose of this study is to measure the amount of moxidectin in subjects' blood and to measure safety. This study will enroll 36 children aged 4 to 11 years (>=12 kg) with or without Onchocerca volvulus (O volvulus) infection. O volvulus is the nematode, or roundworm, that causes Onchocerciasis, also known as river blindness. Each subject will receive a single dose of 4 mg moxidectin (orally administered) and will be followed inpatient from screening through day 13 and as outpatients through month 6. The study will take place at a single research center.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Onchocerciasis
Drug: moxidectin
Single Dose Moxidectin 4 mg
Experimental: Moxidectin
Intervention: Drug: moxidectin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged 4 to 11 years, inclusive (weighing >= 12 kg)
  • With or without O volvulus infection

Exclusion Criteria:

  • Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study
  • Contraindication or hypersensitivity to moxidectin
Sexes Eligible for Study: All
4 Years to 11 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01035619
B1751005
3110A1-2201
Yes
Not Provided
Not Provided
Pfizer
Pfizer
World Health Organization
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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1-800-718-1021

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[email protected]



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