Dose-finding and pharmacokinetic studies of praziquantel in patients infected with Opisthorchis viverrini

Phase 2

Completed

• Conditions: Opisthorchiasis; Infections and Infestations

• Registration Number: ISRCTN77186750
• Lead Sponsor: Swiss Tropical and Public Health Institute (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-27
• Study Completion: 2014-12-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Written informed consent signed by participant
2. Age 15-65 years
3. Able and willing to be examined by a study physician at the beginning of the study and 3 weeks after treatment
4. Able and willing to provide three stool samples at the beginning of the study and 3 weeks after treatment
5. Able and willing to provide 11 finger prick blood samples for PK studies
6. Infected with O. viverrini
7. Absence of major systemic illnesses as assessed by a medical doctor, upon initial clinical assessment
8. No known allergy to study medications

Exclusion Criteria

1. No written informed consent
2. Presence of any abnormal medical condition, judged by the study physician
3. History of acute or severe chronic disease such as liver or renal disease
4. Recent use of anthelminthic drug (within past 4 weeks)
5. Pregnancy or breastfeeding
6. Administration of any investigational product or use of any investigational device within 30 days prior to praziquantel administration. Subjects who have used drugs that may affect thepharmacokinetics of praziquantel from 15 days before dosing until the last PK sample, e.g., phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, oral ketoconazole
7. Consumption of substances known to be potent inhibitors or inducers of CYP P450s such as grapefruit juice, grapefruit juice containing products, and herbal remedies or dietary supplements containing St John?s Wort, in the two weeks before dosing
8. Attending other clinical trials during the study
9. Below 15 years of age
10. Negative diagnostic result for Opisthorchis
11. Allergy to praziquantel

Study & Design

• Study Type: Interventional
• Study Design: Not specified