A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants

NCT02034162 | Completed Phase 3 Results DMC

• 2 other identifiers: CR100933MEBENDAZOLGAI3003
• Study Type: interventional
• Target: 295
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.

Conditions

Helminth Infections

Keywords

Helminth infections; Helminths; Pediatric; Preschool aged; School aged; Mebendazole; Vermox; Placebo

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period

• Maximum Plasma Concentration (Cmax) of Mebendazole

  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

  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

  Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)

Study Arms (2)

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).

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).

Drug: Placebo

Interventions

Mebendazole DRUG

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.

Mebendazole

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Unknown Facility

Gonder, Ethiopia

Location

Unknown Facility

Jimma, Ethiopia

Location

Unknown Facility

Kigali, Rwanda

Location

MeSH Terms

Conditions

Trematode Infections

Interventions

Mebendazole

Condition Hierarchy (Ancestors)

Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: DIRECTOR CLINICAL LEAD
• Organization: Janssen R&D US

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 13, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 4, 2016
• Results First Posted: November 4, 2016

Record last verified: 2016-09

Locations

ET (2); RW (1)