Phase 3 N=295 Randomized Double-blind Treatment

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

Helminth Infections

Bottom Line

View on ClinicalTrials.gov: NCT02034162 ↗

Enrolled (actual)

295

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcome: Primary: Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period — 11.1; 83.7 percentage of participants — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Mebendazole (Drug); Placebo (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Janssen Research & Development, LLC
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period	11.1; 83.7	< 0.001 sig
PRIMARY Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period	7.6; 33.9	< 0.001 sig
PRIMARY Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period	8; 9	—
PRIMARY Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period	7	—
SECONDARY Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period	-19.2; -97.9	< 0.001 sig
SECONDARY Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period	-10.5; -59.7	< 0.001 sig
SECONDARY Maximum Plasma Concentration (Cmax) of Mebendazole	210.0; 49.9; 34.2	—
SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole	2.5; 2; 3	—
SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole	697; 242; 182	—
SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole	1320; 416; 387	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02034162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.