MULTICENTER, RANDOMIZED, DOUBLE-BLIND PARALLEL GROUPS STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF A SINGLE ORAL DOSAGE OF 400 MG OF OXIBENDAZOL AGAINST A SINGLE ORAL DOSAGE OF 500 MG OF MEBENDAZAOL IN THE TREATMENT OF INTESTINAL HELMIANTIASIS IN ADULTS

Not Applicable

• Conditions: -B839 Helminthiasis, unspecified; Helminthiasis, unspecified; B839

• Registration Number: PER-010-01
• Lead Sponsor: SMITHKLINE BEECHAM INTERAMERICAN,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-03-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Informed Consent has been obtained in writing (or orally with a witness).
• Outpatient (male or female) between 18 and 65 years of age.
• In the samples obtained the week prior to recruitment, the patient has one or more of the following helminths: Enterobius vermicularis, Ascaris himbricoides, Trichuris trichiura, Necator americanus, Ancjdostoma duodenalis. (Note: The presence of other helminths is not a cause of exclusion).
• The patient is willing to comply with all protocol requirements and particularly to provide 4 stool samples: Pre-treatment (Day 1) and 7, 14, as well as 21 days after treatment (eg Days 8, 15 and 22) .
• Women patients with reproductive potential will use an established method of birth control (surgical sterilization, intrauterine contraceptive device, oral contraceptives, diaphragms in combination with contraceptive creams or foams, or condoms in combination with contraceptive creams or foams)

Exclusion Criteria

• The patient has previously demonstrated a hypersensitivity reaction to some benzimidazole or other related compounds.
• The patient has diarrheal disease that could interfere with the evaluation of stool samples.
• The patient has received an anthelmintic in the 2 weeks prior to the recruitment of the study.
• The patient has received a research drug at 30 days or 5 half-lives (whichever is longer) from the screening visit, or is scheduled to receive such medication during the study period.
• The patient has a concomitant infection or other underlying disease that could compromise the diagnosis and evaluation of the response to the study medication.
• The patient has a known history of renal dysfunction (plasma creatinine decreased 1.5 times the upper limit normal for age) or liver dysfunction (liver enzymes decreased 1.5 times the upper limit of the range for age).
• Patients who are pregnant, breast-feeding, or who plan a pregnancy during the study or who do not practice any form of birth control
• Patients reluctant or unable to take part in the study.
• Patients previously enrolled in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Absence of helminth eggs (larvae) in the stool examination on Day 15 with the Kato Katz test.<br>Measure:Cure of helminthiasis at Day 15 of follow-up.<br>Timepoints:Day 15<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Stool test, response evaluation<br>Measure:Cure of helminthiasis on Day 8 and 22<br>Timepoints:Day 8 and 22<br>;<br>Outcome name:Stool test using Kato Katz semiquantitative method<br>Measure:Reduction of helminth eggs in the stool sample on Days 8, 15 and 22 in uncured patients.<br>Timepoints:Days 8, 15 and 22<br>;<br>Outcome name:Adverse events report<br>Measure:Safety and Tolerability<br>Timepoints:Day 8, 15 and 22<br>