A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections… (NCT02034162) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
Ethiopia, Rwanda295 participantsStarted 2014-12
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.
Who can participate
Age range
1 Year – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Exclusion Criteria:
* 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, an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period
Timeframe: At Visit 3 (Day 19) of Double-blind treatment period
2
Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period
Timeframe: At Visit 3 (Day 19) of Double-blind treatment period
3
Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period
Timeframe: Up to Visit 3 (Day 19 +/-2)
4
Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period
Timeframe: At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3)