Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT02636803
Status:
WITHDRAWN
Last Update Posted:
2019-08-15
First Post:
2015-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D006725', 'term': 'Hookworm Infections'}], 'ancestors': [{'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017206', 'term': 'Strongylida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011030', 'term': 'oxfendazole'}, {'id': 'D015766', 'term': 'Albendazole'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'not going to be conducted', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2015-12-21', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure of Trichuris trichiura', 'timeFrame': 'day 21 following treatment', 'description': 'Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.'}, {'measure': 'Reduction in Trichuis trichiura eggs (compared to pretreatment)', 'timeFrame': 'day 21 following treatment', 'description': 'Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.'}], 'secondaryOutcomes': [{'measure': 'Cure of other intestinal helminths', 'timeFrame': 'day 21 following treatment', 'description': 'Absence of Ascaris, Necator eggs in stool using Kato Katz test'}, {'measure': 'Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events', 'timeFrame': 'treatment through day 21 following treatment', 'description': 'Cumulative adverse events following treatment up to Day 21'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trichuris', 'hookworms', 'Ascaris'], 'conditions': ['Helminthiasis']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nTwo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written or witnessed oral informed consent has been obtained.\n2. 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.\n3. 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.\n4. 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)\n\nExclusion Criteria:\n\n1. The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.\n2. Presence of other helminths without Trichuris trichiura. Note: Non-target species may be present and details of response will be recorded.\n3. The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.\n4. The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.\n5. 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.\n6. 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.\n7. 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\n8. 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).\n9. Patient that is unwilling or unable to take part in this study.\n10. The patient has previously been enrolled in the study.'}, 'identificationModule': {'nctId': 'NCT02636803', 'briefTitle': 'Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OXF2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxfendazole 6 mg/kg', 'description': 'patients receive 6 mg/kg oxfendazole once', 'interventionNames': ['Drug: oxfendazole']}, {'type': 'EXPERIMENTAL', 'label': 'oxfendazole 30 mg/kg', 'description': 'patients receive 30 mg/kg oxfendazole once', 'interventionNames': ['Drug: oxfendazole']}, {'type': 'EXPERIMENTAL', 'label': 'oxfendazole 6 mg/kg 3 times', 'description': 'patients receive 6 mg/kg oxfendazole three times', 'interventionNames': ['Drug: oxfendazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'albendazole 400 mg', 'description': 'patients receive 400 mg albendazole once', 'interventionNames': ['Drug: albendazole']}], 'interventions': [{'name': 'oxfendazole', 'type': 'DRUG', 'description': 'group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses', 'armGroupLabels': ['oxfendazole 30 mg/kg', 'oxfendazole 6 mg/kg', 'oxfendazole 6 mg/kg 3 times']}, {'name': 'albendazole', 'type': 'DRUG', 'description': 'group receives one 400 mg dose of albendazole', 'armGroupLabels': ['albendazole 400 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert H Gilman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}, {'name': 'Hector H Garcia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Peruana Cayetano Heredia'}, {'name': 'Richard J Horton, MB BChir, MRCGP, FFPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tropical Projects'}, {'name': 'Armando E Gonzalez, DVM, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of San Marcos, Peru'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'posting to CT.gov and publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Peruana Cayetano Heredia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}