WithdrawnPhase 2

Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults

Stopped: not going to be conducted

0Started 2019-11

Plain-language 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. 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).

Who can participate

Age range16 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Written or witnessed oral informed consent has been obtained.

Exclusion criteria

✕. 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)
✕. 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.

What they're measuring

Cure of Trichuris trichiura

Timeframe: day 21 following treatment

Reduction in Trichuis trichiura eggs (compared to pretreatment)

Timeframe: day 21 following treatment

Trial details

NCT IDNCT02636803

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08

View on ClinicalTrials.gov More Helminthiasis trials