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

NCT01173562 | Completed Phase 3

• 2 other identifiers: CR017419MEBENDAZOLGAI3002
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Mebendazole

EXPERIMENTAL

Drug: Mebendazole

Interventions

Mebendazole DRUG

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

Mebendazole

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Pemba, Tanzania

Location

Related Links

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

MeSH Terms

Conditions

Parasitic Diseases; Infections

Interventions

Mebendazole

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

TA (1)