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

Helminth Infections Clinical Trial

Official title:

A Double-Blind, Randomized, Multi-Center, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Dose of a 500-mg Chewable Tablet of Mebendazole in the Treatment of Soil-Transmitted Helminth Infections (Ascaris Lumbricoides and Trichuris Trichiura) in Pediatric Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034162
• Other study ID #: CR100933
• Secondary ID: MEBENDAZOLGAI300
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2014
• Last updated: November 2, 2015
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.

Description:

This will be a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), multi-center, parallel-group study (each group of participants will be treated at the same time) to evaluate the efficacy and safety of mebendazole (a drug currently being investigated for Helminth gastrointestinal infections) compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in children (including pre-school and school-aged children) with Helminth infections. The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and a post-treatment (or follow-up) phase. A pharmacokinetic (explores what a drug does to the body) open-label substudy (asks a separate research question from the parent study while using the same participant population but does not contribute to the parent study's objectives) will be included in the parent study to measure the level of mebendazole in the blood. Safety assessments will be performed throughout the study. Each participant will take part in the study for approximately 30 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• Female participants who are >=9 years old must have a negative urine pregnancy test at screening or at the time of randomization

• Participants must be an otherwise healthy child, based on medical history, physical examination, vital signs, hemoglobin, and concomitant medications

• Participants >=3 years of age must have teeth and be able to chew

• Participant must be available to return to the study site for all visits, including the follow-up visit

• Parent(s)/guardians of participants (or their legally-accepted representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study

• Children 6 years of age and older will be asked to assent (agree) to their participation using appropriate language to their level of understanding; assent will be documented

Exclusion Criteria:

• Participant has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at screening or at the time of randomization

• Participant has a significant medical disorder, participant has difficulty in chewing or swallowing

• Participant has significant anemia (<8 g/dL)

• Participant has significant wasting (greater than 2 standard deviations below the mean World Health Organization [WHO] Child Growth Standards for weight-for-height or body mass index)

• Participant has a known hypersensitivity to mebendazole, any inert ingredients in the chewable formulation

• Participant has preplanned surgery/procedures that would interfere with the conduct of the study during the course of study

• Participants has received an investigational drug (including vaccines) or used an investigational medical device within 30 days before the planned start of treatment, or is currently enrolled in an investigational study

• Employees of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

• Participant has taken any form of medication containing mebendazole or any other treatment for soil transmitted helminth infection within 30 days of entry into the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Helminth Infections
• Helminthiasis
• Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Ethiopia,  Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate for A. lumbricoides for those participants with a positive egg count for that soil-transmitted helminth at baseline	Cure is defined as a posttreatment egg count of zero in participants who had a positive egg count at baseline.	Baseline (Day 1) to Day 20	No
Primary	Cure rate for T. trichiura for those participants with a positive egg count for that soil-transmitted helminth at baseline	Cure is defined as a posttreatment egg count of zero in participants who had a positive egg count at baseline.	Baseline (Day 1) to Day 20	No
Secondary	The percentage egg reduction for A. lumbricoides for those participants with a positive egg count for that soil-transmitted helminth at baseline	Egg count at end of treatment period minus egg count at baseline divided by egg count at baseline multiplied by 100%.	Baseline (Day 1) to Day 20	No
Secondary	The percentage egg reduction for T. trichiura for those participants with a positive egg count for that soil-transmitted helminth at baseline	Egg count at end of treatment period minus egg count at baseline divided by egg count at baseline multiplied by 100%.	Baseline (Day 1) to Day 20	No