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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT01173562

Collaborator

(none)

397

Enrollment

Location

Arm

Duration (Days)

431.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Mebendazole	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

397 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Single-Dose Study to Assess the Safety of 500-mg Mebendazole Chewable Formulation in Children 2 to 10 Years of Age, Inclusive

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mebendazole	Drug: Mebendazole Type= exact number, unit= mg, number= 500, form= chewable tablet, route= oral use. One mebendazole 500-mg chewable tablet taken on Day 1.

Arm

Intervention/Treatment

Experimental: Mebendazole

Drug: Mebendazole

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

Outcome Measures

Primary Outcome Measures

The number, severity, relationship to study drug, and type of adverse events reported. [Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit]

Secondary Outcome Measures

Change in physical examination [Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit]
Change in vital sign measurements [Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Pemba		Tanzania

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.