Pediatric Pharmacokinetics And Safety Study Of Moxidectin
NCT01035619
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
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OnchocerciasisPediatric Pharmacokinetics And Safety Study Of Moxidectin
NCT01035619
ALL GENDERS
4 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Pediatric Pharmacokinetics And Safety Study Of Moxidectin | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Onchocerciasis | |||
| Intervention ICMJE | Drug: moxidectin
Single Dose Moxidectin 4 mg | |||
| Study Arms ICMJE | Experimental: Moxidectin
Intervention: Drug: moxidectin | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Withdrawn | |||
| Actual Enrollment ICMJE | 0 | |||
| Original Estimated Enrollment ICMJE | 36 | |||
| Actual Study Completion Date ICMJE | April 2011 | |||
| Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 4 Years to 11 Years (Child) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01035619 | |||
| Other Study ID Numbers ICMJE | B1751005 3110A1-2201 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | World Health Organization | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||