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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02034162 |
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Date of registration:
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09/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
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Scientific title:
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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 |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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295 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02034162 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Ethiopia
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Rwanda
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Contacts
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Name:
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Janssen Research & Development, LLC Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Research & Development, LLC |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
16 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Helminth Infections
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Intervention(s)
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Drug: Placebo
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Drug: Mebendazole
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Primary Outcome(s)
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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]
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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)]
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Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period
[Time Frame: Up to Visit 3 (Day 19 +/-2)]
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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]
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Secondary Outcome(s)
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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]
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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)]
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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)]
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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)]
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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]
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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)]
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Secondary ID(s)
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CR100933
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MEBENDAZOLGAI3003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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