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CompletedNCT01173562Updated Mar 12, 2014

A Safety Study of Mebendazole in Children 2 to 10 Years of Age

A Phase 3 interventional study of Mebendazole in Healthy Volunteers, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 1 site in Tanzania. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-12.

Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
397
Allocation
Not applicable
Ages
2 Years to 10 Years
Sex
All
01

Study summary

The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the treatment of soil-transmitted parasitic helminth (STH) (ie, parasitic worm) infections such as pinworm, whipworm, common roundworm, common hookworm, and American hookworm.

Read the detailed description

This is an open-label (identity of study drug will be known to study participant and investigator), single-center, single-dose, single-arm (ie, 1 treatment group) safety study. This study will consist of a screening visit on Day 1 at which time all study-related screening procedures will be performed. After all results are reviewed, children who meet all of the inclusion criteria and none of the exclusion criteria will be entered into the open-label phase of the study. A single mebendazole 500-mg chewable tablet will be administered on Day 1 and the children will remain at the study site so that adverse events can be recorded at approximately 30 minutes postdose. Study participants will return to the study site 3 days (plus or minus 1 day) postdose at which time adverse events will be recorded again. Safety will be monitored during the study by assessing adverse events by direct observation at 30 minutes after dosing and at 3 days (plus or minus 1 day) after dosing, by direct observation of the study participant, report by the parent or guardian, or both. On Day 1, a single mebendazole 500-mg chewable tablet will be chewed and swallowed by each study participant. If desired, study participants will be allowed to drink water when administered study drug.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Healthy volunteers
  • Parasitic Diseases
  • Mebendazole (VERMOX)
  • Anthelmintics
  • Antiparasitic Agents
  • Soil-transmitted helminth (STH) infections
  • Pediatric
03

In context

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Be an otherwise healthy child based on medical history, physical examination, vital signs, and concomitant medications and live in a high-prevalence area where parasite infection is endemic (ie, Prevalent in or peculiar to a particular locality, region, or people)
  • Have teeth and be able to chew the mebendazole chewable tablet
  • Girls must be premenarchal
  • Parent(s)/guardians of study 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

Exclusion criteria

Exclusion Criteria:

  • Have a history of clinically significant liver or renal insufficiency
  • cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (eg, anemia), rheumatologic, psychiatric, or metabolic disturbances that, in the opinion of the investigator, renders the candidate not suitable for mebendazole treatment
  • Have a suspected massive intestinal parasitic infection, based on history and physical findings, as determined by the principal investigator
  • Have any condition that, in the opinion of the investigator, would compromise the well-being of the study participant or the study or prevent the study participant from meeting or performing study requirements
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
397 participants (actual)

Study arms

  • Experimental
    Mebendazole

    Drug: Mebendazole

Interventions

  • DrugMebendazole

    Type= exact number, unit= mg, number= 500, form= chewable tablet, route= oral use. One mebendazole 500-mg chewable tablet taken on Day 1.

06

What researchers measure

Primary outcomes

  1. The number, severity, relationship to study drug, and type of adverse events reported.

    Time frame: Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit

Secondary outcomes

  1. Change in physical examination

    Time frame: Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit

  2. Change in vital sign measurements

    Time frame: Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit

07

Study locations

1 site
  • Pemba, Tanzania
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01173562
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible party
Sponsor
First posted
Aug 2, 2010
Start date
Feb 2010
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Mar 12, 2014

Study contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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