Assessment of Drug Efficacy of Local Albendazole

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Infections with soil-transmitted helminthes (STH) occur throughout the developing world and remain a major public health problem in the poorest communities. Preventive chemotherapy (PC) programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the drugs of choice for STH - are administered at the population level, is the main strategy for STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK) (albendazole (ALB), Zentel) and Johnson & Johnson (mebendazole (MEB), Vermox). In addition to this, there are a wide variety of ALB and MEB tablets available on the local market. Although little is known about the quality of anthelmintics sold for human use, several publications have reported variability in the quality of generic anthelmintics used in veterinary medicine. The main objective of the present study is to compare the efficacy of two ALB brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical) and BENDEX (India, Cipla)

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Ghent
• Treatments: Albendazole

Criteria

Inclusion Criteria:

1. Age: 5-18 years old.

2. Sex: males and females.

3. Signed of written informed consent sheet by parents/or guardians, and those who volunteered to comply with study procedures (stool submission, drug treatment).

4. Females: was not pregnant (as verbally assessed by clinician upon enrolled to treatment).

Exclusion Criteria:

1. Had vomit within 4 hours after drug administration.

2. Had diarrhea at time of the first sampling.

3. Subjects who were unable to provide a stool sample at follow-up,

4. Subjects who experienced a severe concurrent medical condition

5. Subjects with known history of allergic reaction to ALB.