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Efficacy of Oxfendazole in the Treatment of Trichuris Trichiura Infection in Adults

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ClinicalTrials.gov Identifier: NCT03435718
Recruitment Status : Not yet recruiting
First Posted : February 16, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Universidad Peruana Cayetano Heredia, Lima, Peru
Information provided by (Responsible Party):
Oxfendazole Development Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Trichuris Infection Drug: Oxfendazole Drug: Albendazole Phase 2

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: An Assessor Blind, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OXF6
Patients receive a single 6 mg/kg dose of oxfendazole administered orally.
Drug: Oxfendazole
oral suspension

Experimental: OXF15
Patients receive a single 15 mg/kg dose of oxfendazole administered orally.
Drug: Oxfendazole
oral suspension

Experimental: OXF30
Patients receive a single 30 mg/kg dose of oxfendazole administered orally.
Drug: Oxfendazole
oral suspension

Experimental: OXF15x3
Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days.
Drug: Oxfendazole
oral suspension

Active Comparator: ALB400
Patients receive a single 400 mg/kg dose of albendazole administered orally.
Drug: Albendazole
tablet




Primary Outcome Measures :
  1. cure d14 [ Time Frame: Day 14 of follow up ]
    absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

  2. cure d7 [ Time Frame: Day 7 of follow up ]
    absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients


Secondary Outcome Measures :
  1. improvement d21 [ Time Frame: Day 21 of follow up ]
    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

  2. improvement d14 [ Time Frame: Day 14 of follow up ]
    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

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7 [ Time Frame: Day 7 of follow up ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14 [ Time Frame: Day 14 of follow up ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21 [ Time Frame: Day 21 of follow up ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female outpatient, more than 18 years and less than 65 years of age.
  2. Written or witnessed oral informed consent has been obtained.
  3. Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis or other helminths will not be a cause for exclusion.
  4. Willingness to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
  5. Female patients of child bearing potential, who are using an established method of birth control (surgically sterile, intra-uterine contraceptive device, oral contraceptives, diaphragm in combination with contraceptive cream or foam, or condom in combination with contraceptive cream or foam) may be included

Exclusion Criteria:

  1. The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
  2. Presence of other helminths without Trichuris trichiura. Non-target species may be present and details of response will be recorded.
  3. The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
  4. The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
  5. The patient has received an investigational drug within 30 days or 5 half-lives (whichever is longer) of the screening visit or is scheduled to receive such a drug during the study period.
  6. The patient has a concomitant infection or any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication.
  7. The patient has a known history of renal dysfunction or plasma creatinine ≥ 1.5 times upper limit of normal for age or a known history of hepatic dysfunction or liver enzymes ≥ 1.5 times upper limit of normal.
  8. The patient is a female who is pregnant, lactating or planning a pregnancy during the study, or is not practicing any form of contraception (see inclusion criteria (4.2.5).
  9. The patient is unwilling or unable to take part in this study.
  10. The patient has previously been enrolled in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435718


Contacts
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Contact: ellen codd, MS 484 557 3831 ellen.codd@oxfendazoledevelopmentgroup.org

Sponsors and Collaborators
Oxfendazole Development Group
Universidad Peruana Cayetano Heredia, Lima, Peru
Investigators
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Principal Investigator: Héctor Hugo Garcia, MD PhD Oxfendazole Development Group

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Responsible Party: Oxfendazole Development Group
ClinicalTrials.gov Identifier: NCT03435718     History of Changes
Other Study ID Numbers: OXF2 v3.21
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data will be uploaded to the clinicaltrials.gov website, and a publication will be prepared

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oxfendazole Development Group:
oxfendazole
albendazole
Trichuris trichiura
Additional relevant MeSH terms:
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Oxfendazole
Infection
Communicable Diseases
Trichuriasis
Enoplida Infections
Adenophorea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents