A RANDOMIZED, PARALLEL GROUP, OPEN LABEL STUDY TO EVALUATE DOSE RESPONSE, EFFICENCY, SAFETY AND TOLERABILITY OF A SINGLE DOSE OF 200 MG, 400 MG OR 800 MG OF OXIBENDAZOLE IN THE TREATMENT OF INFECTIONS BY TRICHURIS TRICHURA IN ADULTS

SMITHKLINE BEECHAM INTERAMERICAN,0 个研究点目标入组 0 人开始时间: 1999年1月28日最近更新: 2023年9月4日

适应症

试验速览

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•1. External Patient, male or female between 18 and 65 years old
•a. Spoken or written consent must be obtained.
•b. To have infection by trichuris trichiura, shown in the stool samples obtained during the week before. Presence
•of any other type of helminths will not be cause for exclusion.
•2. To be willing to fulfill the mentioned requirements and particularly to provide 3 stool samples on days 7, 14,
•21 after treatment.
•3. Female patients with potential to become pregnant, who have used an established method of birth control
•(surgical sterilization, intra-uterine contraceptive device, oral contraceptives, diaphragm in combination with
•contraceptive creams or foam, or condom in combination with contraceptive creams or foam) .

•1. The patient who has previously demonstrated a hypersensitivity reaction to benzimidazole or other related compounds.
•2. Submitted patients who are not infected with Trichuris trichiura. Other species may also be present and the details of the response will be recorded.
•3. The patient with diarrheal disease that could interfere with the evaluation of the stool sample and / or the patient has signs of dehydration.
•4. The patient has received an anthelmintic in the 2 weeks prior to enrollment or study.
•5. The patient has received an investigational drug within thirty days or five half-lives (whichever is the extension) of the screening visit or is scheduled to receive such a drug during the study period.
•6. The patient has a concomitant infection or some other underlying disease which could compromise the diagnosis and evaluation of the response to study medication.
•7. The patient has a known history of renal dysfunction (plasma creatinine> or = 1.5 times at the upper limit normal for age), or hepatic dysfunction (liver enzymes> or = 1.5 times at the upper limit of the range for age).
•8. A woman who is pregnant, lactating or planning a pregnancy during the study or is not practicing any form of contraception.
•9. The patient who is reluctant or unable to take part in this study.
•10. The patient who has previously been enrolled in this study.

发起方

SMITHKLINE BEECHAM INTERAMERICAN,