A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants

PHASE3CompletedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Helminth Infections
Interventions
DRUG

Mebendazole

Mebendazole will be administered as a single-dose 500 mg chewable tablet. For children 1 year to \<36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.

DRUG

Placebo

Matching placebo will be administered as a single-dose chewable tablet. For children 1 year to \<36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.

Trial Locations (3)

Unknown

Gonder

Jimma

Kigali

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02034162 - A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants | Biotech Hunter | Biotech Hunter