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Label indication VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ). FDA label
Mebendazole · 1 trial · 1 indication
Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.
Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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). |
| 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). |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
Inclusion Criteria: * 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 medicat...
Mebendazole is a small molecule drug being developed for the treatment of helminth infections, which are parasitic worm infections. It is being studied in pediatric participants aged 1 year and older. The development program includes a Phase 3 trial in Ethiopia and Rwanda.
Mebendazole is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting a Phase 3 study of the drug for helminth infections in pediatric participants.
Mebendazole is in Phase 3 clinical development for helminth infections. One Phase 3 trial has been completed, and there are currently no active trials listed. The drug has not been approved by the FDA for this indication and remains investigational.
Mebendazole has been studied in a completed Phase 3 trial, NCT02034162, titled "A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants." The trial enrolled 295 participants in Ethiopia and Rwanda and was randomized, double-blind, and placebo-controlled.
Yes, Mebendazole - fasted state (Treatment A), Mebendazole - fasted state, Mebendazole - fed state (Treatment B), and Mebendazole - fed state are alternative names or treatment conditions for the same drug, Mebendazole. These terms refer to the drug administered under different fasting or fed conditions in clinical studies.