Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300768
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2006-03-07
Brief Title:
Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
Sponsor:
Medicines Development for Global Health
Organization:
Medicines Development for Global Health
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study was to determine the safety and tolerability of moxidectin in subjects infected with Onchocerca volvulus a parasitic worm
Detailed Description:
This was a phase 2 randomized ivermectin-controlled double-blind single-ascending-dose parallel design inpatientoutpatient study of moxidectin administered to subjects of both sexes with different degrees of severity of O volvulus infection The study was conducted at a single site in Ghana
Secondary objects are to determine the pharmacokinetics of moxidectin to obtain initial indication of the efficacy in terms of long term effect on skin microfilaria levels and an indication of the effect on the macrofilaria that may underlie the effect on skin microfilaria levels
Subjects were enrolled in consecutive cohorts to receive a single oral dose of 2 mg 4 mg or 8 mg or moxidectin or ivermectin 150 µgkg by severity of infection based on the mean of the skin microfilariae densities at each of 4 body locations both iliac crests and calves
Secondary objects are to determine the pharmacokinetics of moxidectin to obtain initial indication of the efficacy in terms of long term effect on skin microfilaria levels and an indication of the effect on the macrofilaria that may underlie the effect on skin microfilaria levels
Subjects were enrolled in consecutive cohorts to receive a single oral dose of 2 mg 4 mg or 8 mg or moxidectin or ivermectin 150 µgkg by severity of infection based on the mean of the skin microfilariae densities at each of 4 body locations both iliac crests and calves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OCRC 33 | OTHER | Protocol ID WHO OCRC | None |
| B1751004 | OTHER | None | None |