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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 S

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

Detailed Summary: 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.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome:

  • Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period [ Time Frame: At Visit 3 (Day 19) of Double-blind treatment period ]
    Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.
  • Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period [ Time Frame: At Visit 3 (Day 19) of Double-blind treatment period ]
    Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.
  • Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period [ Time Frame: Up to Visit 3 (Day 19 +/-2) ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period [ Time Frame: At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3) ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any

    Original Primary Outcome:

    • Cure rate for A. lumbricoides for those participants with a positive egg count for that soil-transmitted helminth at baseline [ Time Frame: Baseline (Day 1) to Day 20 ]
      Cure is defined as a posttreatment egg count of zero in participants who had a positive egg count at baseline.
    • Cure rate for T. trichiura for those participants with a positive egg count for that soil-transmitted helminth at baseline [ Time Frame: Baseline (Day 1) to Day 20 ]
      Cure is defined as a posttreatment egg count of zero in participants who had a positive egg count at baseline.


    Current Secondary Outcome:

    • Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period [ Time Frame: Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period ]
      Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.
    • Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period [ Time Frame: Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period ]
      Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.
    • Maximum Plasma Concentration (Cmax) of Mebendazole [ Time Frame: Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) ]
      The Cmax is the maximum plasma concentration.
    • Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole [ Time Frame: Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) ]
      The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration.
    • Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole [ Time Frame: Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) ]
      The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose.
    • Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole [ Time Frame: Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) ]
      The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.


    Original Secondary Outcome:

    • The percentage egg reduction for A. lumbricoides for those participants with a positive egg count for that soil-transmitted helminth at baseline [ Time Frame: Baseline (Day 1) to Day 20 ]
      Egg count at end of treatment period minus egg count at baseline divided by egg count at baseline multiplied by 100%.
    • The percentage egg reduction for T. trichiura for those participants with a positive egg count for that soil-transmitted helminth at baseline [ Time Frame: Baseline (Day 1) to Day 20 ]
      Egg count at end of treatment period minus egg count at baseline divided by egg count at baseline multiplied by 100%.


    Information By: Janssen Research & Development, LLC

    Dates:
    Date Received: January 9, 2014
    Date Started: December 2014
    Date Completion:
    Last Updated: September 16, 2016
    Last Verified: September 2016