Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-20 @ 12:55 PM
Study NCT ID:
NCT02385058
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2015-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
Sponsor:
Janssen-Cilag Ltd.
Organization:
Study Overview
Official Title:
Double-Blind, Placebo-Controlled, Randomized, Prospective, Two-Stage, Two-Arm Study to Evaluate the Efficaciousness and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
Status:
COMPLETED
Status Verified Date:
2015-04
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 purpose of this study is to assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in Mexican population.
Detailed Description:
This is a double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), randomized (study medication assigned to participants by chance), prospective (study following patients forward in time) study. The total study duration for each participant will be approximately 48 days. The study will consist of 3 parts: Screening Phase (5 days) and double-blind treatment Phase (from Day 1 to 21, consists of Phase-1 and Phase-2) and follow-up Phase (from Day 21 to 43). Participants will receive mebendazole (600 milligram \[mg\]) and quinfamide (200 mg) tablets orally once starting on Day 1 and mebendazole 600 mg and quinfamide (200 mg) or placebo tablets orally once starting on Day 21. Efficacy will be primarily evaluated by percentage of participants with eradication of helminthic and/or protozoa. Participants' safety will be monitored throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: