A Phase 2 interventional study of Oxantel Pamoate and Mebendazole in Trichuris Trichiura; Infection, Hookworm Infection and Ascaris Lumbricoides Infection, sponsored by Jennifer Keiser. Completed at 1 site in Tanzania. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Jennifer Keiser · Phase 2, Interventional, and Treatment
This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 163 is below the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Jennifer Keiser is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with oxantel pamoate (20 mg/kg), orally administered on day 0
Drug: Oxantel Pamoate
Treatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2
Drug: Oxantel Pamoate
Mebendazole (500mg), orally administered on day 0
Drug: Mebendazole
Tablets containing 250 mg oxantel pamoate
Tablets containing 500 mg mebendazole
Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 14-21 days after treatment
Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 14-21 days after treatment
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Time frame: 14-21 days after treatment
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Time frame: 14-21 days after treatment
Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Time frame: 14-21 days after treatment
Number of adverse events (AE) to assess safety and tolerability of oxantel pamoate administered as a single dose or as multiple doses, and compared with mebendazole
Participants will be monitored at the site for 3 hours following treatment for any acute AEs. Participants will be interviewed 3 hours after treatment, as well as 24 hours after every dose received, as well as 14-21days after the last treatment dose about the occurrence of AEs. AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment.
Time frame: 3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Jennifer Keiser