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| Name | Class |
|---|---|
| Universidad Peruana Cayetano Heredia | OTHER |
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The main objective of this study is to provide data on the efficacy profile of different doses of oxfendazole when used in Trichuris trichiura infection. The drug will be also be examined for efficacy against other common nematodes encountered in man (Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus). The study will also provide data on the safety and tolerability of the oxfendazole in patients.
This is an assessor blind, randomized, comparative study in adult patients with proven intestinal infection with Trichuris trichiura to be conducted as a field study. Patients meeting the study entry criteria will receive either 6 mg/kg or 15 mg/kg or 30 mg/kg of oxfendazole as a single oral dose, three single doses of oxfendazole on consecutive days, or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined prior to treatment and at 7, 14 and 21 days after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OXF6 | Experimental | Patients receive a single 6 mg/kg dose of oxfendazole administered orally. |
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| OXF15 | Experimental | Patients receive a single 15 mg/kg dose of oxfendazole administered orally. |
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| OXF30 | Experimental | Patients receive a single 30 mg/kg dose of oxfendazole administered orally. |
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| OXF15x3 | Experimental | Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days. |
|
| ALB400 | Active Comparator | Patients receive a single 400 mg/kg dose of albendazole administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxfendazole | Drug | oral suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| cure d14 | absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients | Day 14 of follow up |
| cure d7 | absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients | Day 7 of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| improvement d21 | reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients | Day 21 of follow up |
| improvement d14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ellen codd, MS | Contact | 484 557 3831 | ellen.codd@oxfendazoledevelopmentgroup.org |
| Name | Affiliation | Role |
|---|---|---|
| Héctor Hugo Garcia, MD PhD | Oxfendazole Development Group | Principal Investigator |
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The data will be uploaded to the clinicaltrials.gov website, and a publication will be prepared
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| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| C011030 | oxfendazole |
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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This study will be conducted as a field trial. Patients will be randomly assigned to one of five treatment groups: 6 mg/kg, 15 mg/kg or 30 mg/kg oxfendazole as a single dose; 15 mg/kg oxfendazole on three consecutive days; or 400 mg albendazole as a single dose (50 patients per group). The main objective of this study is to assess the efficacy (Cure Rate) of oral oxfendazole. Secondary objectives are to assess the Egg Reduction Rate for Trichuris in those subjects not cured of infection, to assess the efficacy (Cure Rate and Egg Reduction Rate) of oxfendazole against other common intestinal helminth infections, and to assess the safety and tolerability of oxfendazole treatment in adult patients.
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Each patient's treatment condition will be masked by a code assigned at randomization. The study pharmacist will know this assignment. A person other than the investigator will administer the drug as directed by the pharmacists.
| Albendazole |
| Drug |
tablet |
|
reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
| Day 14 of follow up |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Day 7 of follow up |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Day 14 of follow up |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Day 21 of follow up |
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |