Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT03435718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-08
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Oxfendazole in the Treatment of Trichuris Trichiura Infection in Adults
Sponsor:
Oxfendazole Development Group
Organization:
Study Overview
Official Title:
An Assessor Blind, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 main objective of this study is to provide data on the efficacy profile of different doses of oxfendazole when used in Trichuris trichiura infection. The drug will be also be examined for efficacy against other common nematodes encountered in man (Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus). The study will also provide data on the safety and tolerability of the oxfendazole in patients.
Detailed Description:
This is an assessor blind, randomized, comparative study in adult patients with proven intestinal infection with Trichuris trichiura to be conducted as a field study. Patients meeting the study entry criteria will receive either 6 mg/kg or 15 mg/kg or 30 mg/kg of oxfendazole as a single oral dose, three single doses of oxfendazole on consecutive days, or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined prior to treatment and at 7, 14 and 21 days after treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: