Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mebendazole · 2 trials · 2 indications
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 used for the treatment of helminth infections in pediatric participants. It has also been studied in healthy volunteers to assess its safety in children aged 2 to 10 years. The drug is a small molecule being developed by Johnson & Johnson.
Mebendazole is being developed by Johnson & Johnson, a company listed on the stock exchange under the ticker JNJ. The drug is currently in Phase 3 clinical development for helminth infections and has completed trials in healthy volunteers.
Mebendazole is in Phase 3 clinical development. It has completed two Phase 3 trials, one assessing safety in children aged 2 to 10 years and another evaluating efficacy and safety for helminth infections in pediatric participants. The drug is investigational and not yet approved.
Mebendazole has been studied in two completed Phase 3 trials. NCT01173562 assessed safety in 397 healthy children aged 2 to 10 years in Tanzania. NCT02034162 evaluated efficacy and safety in 295 pediatric participants with helminth infections in Ethiopia and Rwanda.
Mebendazole is also known by the brand name Vermox. It is an anthelmintic drug used to treat parasitic worm infections. In clinical trials, it has been studied for safety in healthy children and for treatment of helminth infections in pediatric populations.