HelminthiasisPhase 2NCT02636803
Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
A Phase 2 study testing oxfendazole and albendazole in people with Helminthiasis, run by Johns Hopkins Bloomberg School of Public Health.
Trial summary
The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Helminthiasis
- What is being tested?
- oxfendazole and albendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written or witnessed oral informed consent has been obtained.
- Has Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of other helminths: Enterobius vermicularis, Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis will not be a cause for exclusion.
- Is willing to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
- 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)
Who cannot join
- The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
- Presence of other helminths without Trichuris trichiura. Note: Non-target species may be present and details of response will be recorded.
- The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
- The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
- 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.
- 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.
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- The patient has a known history of renal dysfunction (plasma creatinine ≥ 1.5 times upper limit of normal for age) or hepatic dysfunction (liver enzymes ≥ 1.5
- 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).
- Patient that is unwilling or unable to take part in this study.
- The patient has previously been enrolled in the study.
About this study
Official title: An Open Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. In addition, the study will provide data on oxfendazole efficacy against other common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenalis, Necator americanus).
Read the detailed description
This is an open, comparative study in adult patients with proven intestinal infection with Trichuris trichiura. Patients meeting the study entry criteria will receive either 6mg/kg, or 30 mg/kg of oxfendazole as a single oral dose or 6 mg/kg orally for three days or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined 7, 14 and 21 days after treatment.
Two hundred clinically evaluable patients of either gender, 16 - 65 years of age, presenting with proven Trichuris trichiura infection, recruited from one centre, will be included in the study. there will be 15 patients in each treatment group. Duration of accrual will be determined in discussion with the clinical site in Iquitos, Peru.
- Conditions
- Helminthiasis
- Being tested
- oxfendazole, albendazole
- Keywords
- trichuris, hookworms, Ascaris
- Medical subject headings
- Helminthiasis, Hookworm Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxfendazoleDrug
group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses
albendazoleDrug
group receives one 400 mg dose of albendazole
| Study group | Role | What they receive |
|---|---|---|
| oxfendazole 6 mg/kg | Experimental | patients receive 6 mg/kg oxfendazole once Receives: Drug: oxfendazole |
| oxfendazole 30 mg/kg | Experimental | patients receive 30 mg/kg oxfendazole once Receives: Drug: oxfendazole |
| oxfendazole 6 mg/kg 3 times | Experimental | patients receive 6 mg/kg oxfendazole three times Receives: Drug: oxfendazole |
| albendazole 400 mg | Active comparator | patients receive 400 mg albendazole once Receives: Drug: albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of Trichuris trichiura
Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.
Measured: day 21 following treatment
Reduction in Trichuis trichiura eggs (compared to pretreatment)
Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.
Measured: day 21 following treatment
Secondary outcomes (2)
Cure of other intestinal helminths
Absence of Ascaris, Necator eggs in stool using Kato Katz test
Measured: day 21 following treatment
Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events
Cumulative adverse events following treatment up to Day 21
Measured: treatment through day 21 following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startNov 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: not going to be conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HelminthiasisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia
- Responsible party
- Sponsor
- Investigators
- Robert H Gilman, MD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthHector H Garcia, MD, PhD, Principal investigator, Universidad Peruana Cayetano HerediaRichard J Horton, MB BChir, MRCGP, FFPM, Principal investigator, Tropical ProjectsArmando E Gonzalez, DVM, PhD, Principal investigator, National University of San Marcos, Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636803
- Sponsor's protocol ID
- OXF2
- Status last verified
- Aug 2019
- First submitted
- 14 Dec 2015
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: posting to CT.gov and publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
- ClinicalTrials.gov ID
- NCT02636803
- Acronym / sponsor ID
- OXF2
- Conditions
- Helminthiasis
- Keywords
- trichuris, hookworms, Ascaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not going to be conducted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia
- Study start
- Nov 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. In addition, the study will provide data on oxfendazole efficacy against other common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenalis, Necator americanus).
Detailed description
This is an open, comparative study in adult patients with proven intestinal infection with Trichuris trichiura. Patients meeting the study entry criteria will receive either 6mg/kg, or 30 mg/kg of oxfendazole as a single oral dose or 6 mg/kg orally for three days or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined 7, 14 and 21 days after treatment.
Two hundred clinically evaluable patients of either gender, 16 - 65 years of age, presenting with proven Trichuris trichiura infection, recruited from one centre, will be included in the study. there will be 15 patients in each treatment group. Duration of accrual will be determined in discussion with the clinical site in Iquitos, Peru.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| oxfendazole 6 mg/kg | Experimental | Drug: oxfendazolepatients receive 6 mg/kg oxfendazole once |
| oxfendazole 30 mg/kg | Experimental | Drug: oxfendazolepatients receive 30 mg/kg oxfendazole once |
| oxfendazole 6 mg/kg 3 times | Experimental | Drug: oxfendazolepatients receive 6 mg/kg oxfendazole three times |
| albendazole 400 mg | Active comparator | Drug: albendazolepatients receive 400 mg albendazole once |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Written or witnessed oral informed consent has been obtained.
- Has Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of other helminths: Enterobius vermicularis, Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis will not be a cause for exclusion.
- Is willing to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
- 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)
Key exclusion criteria (10 listed)
- The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
- Presence of other helminths without Trichuris trichiura. Note: Non-target species may be present and details of response will be recorded.
- The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
- The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxfendazolegroup receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses | Drug | oxfendazole 30 mg/kg, oxfendazole 6 mg/kg, oxfendazole 6 mg/kg 3 times |
| albendazolegroup receives one 400 mg dose of albendazole | Drug | albendazole 400 mg |
Primary outcome
Cure of Trichuris trichiura
Time frame: day 21 following treatment
Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.
Reduction in Trichuis trichiura eggs (compared to pretreatment)
Time frame: day 21 following treatment
Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.
2 secondary outcomes
Cure of other intestinal helminths
Time frame: day 21 following treatment
Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events
Time frame: treatment through day 21 following treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: Yes. posting to CT.gov and publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Gilman, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
Hector H Garcia, MD, PhD principal investigator
Universidad Peruana Cayetano Heredia
Richard J Horton, MB BChir, MRCGP, FFPM principal investigator
Tropical Projects
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxfendazole and albendazole in people with Helminthiasis, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure of Trichuris trichiura (time frame: day 21 following treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.