Helminth InfectionsPhase 3NCT02034162
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
A Phase 3 study testing Mebendazole in people with Helminth Infections, run by Janssen Research & Development, LLC at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Helminth Infections
- What is being tested?
- Mebendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2014to Sep 2015
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
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
The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.
Read the 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.
- Conditions
- Helminth Infections
- Being tested
- Mebendazole, Placebo
- Keywords
- Helminth infections, Helminths, Pediatric, Preschool aged, School aged, Mebendazole, Vermox, Placebo
- Medical subject headings
- Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MebendazoleDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Mebendazole | Active comparator | 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). Receives: Drug: Mebendazole |
| Placebo | Placebo comparator | Matching placebo will be administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Visit 3 (Day 19) of Double-blind treatment period
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.
Measured: At Visit 3 (Day 19) of Double-blind treatment period
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.
Measured: Up to Visit 3 (Day 19 +/-2)
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.
Measured: At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3)
Secondary outcomes (6)
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.
Measured: Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period
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.
Measured: Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period
Maximum Plasma Concentration (Cmax) of Mebendazole
The Cmax is the maximum plasma concentration.
Measured: Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)
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.
Measured: Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)
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.
Measured: Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)
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.
Measured: Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Helminth InfectionsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034162
- Sponsor's protocol ID
- CR100933
- Other IDs
- MEBENDAZOLGAI3003
- Status last verified
- Sep 2016
- First submitted
- 9 Jan 2014
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes