Back to resultsA Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
Primary Purpose
Helminth Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mebendazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Helminth Infections focused on measuring Helminth infections, Helminths, Pediatric, Preschool aged, School aged, Mebendazole, Vermox, Placebo
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mebendazole
Placebo
Arm Description
Mebendazole will be administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) and in an open-label manner at Visit 4 (Day 21).
Matching placebo will be administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1).
Outcomes
Primary Outcome Measures
Cure Rate for Ascaris Lumbricoides at the End 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
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
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
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.
Secondary Outcome Measures
Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation 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
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
The Cmax is the maximum plasma concentration.
Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole
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
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
The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
Full Information
NCT ID
NCT02034162
First Posted
January 9, 2014
Last Updated
September 16, 2016
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02034162
Brief Title
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helminth Infections
Keywords
Helminth infections, Helminths, Pediatric, Preschool aged, School aged, Mebendazole, Vermox, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mebendazole
Arm Type
Active Comparator
Arm Description
Mebendazole will be administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) and in an open-label manner at Visit 4 (Day 21).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo will be administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1).
Intervention Type
Drug
Intervention Name(s)
Mebendazole
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period
Description
Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.
Time Frame
At Visit 3 (Day 19) of Double-blind treatment period
Title
Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period
Description
Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.
Time Frame
At Visit 3 (Day 19) of Double-blind treatment period
Title
Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period
Description
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.
Time Frame
Up to Visit 3 (Day 19 +/-2)
Title
Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period
Description
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.
Time Frame
At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3)
Secondary Outcome Measure Information:
Title
Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period
Description
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.
Time Frame
Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period
Title
Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period
Description
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.
Time Frame
Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period
Title
Maximum Plasma Concentration (Cmax) of Mebendazole
Description
The Cmax is the maximum plasma concentration.
Time Frame
Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)
Title
Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole
Description
The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration.
Time Frame
Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)
Title
Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole
Description
The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose.
Time Frame
Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)
Title
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole
Description
The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
Time Frame
Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Gondar
Country
Ethiopia
City
Jimma
Country
Ethiopia
City
Kigali
Country
Rwanda
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
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