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Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections

Information source: University of Kelaniya
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Necator Americanus Infection

Intervention: Mebendazole polymorph A and C 500 mg (Drug); Mebendazole polymorph C (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Kelaniya

Official(s) and/or principal investigator(s):
Nilanthi R de Silva, MD, Principal Investigator, Affiliation: Faculty of Medicine, University of Kelaniya, Sri Lanka

Summary

Mebendazole tablets which are produced by most pharmaceutical manufacturers, including the State Pharmaceutical Manufacturing Corporation (SPMC) of Sri Lanka, contain a mixture of polymorphs A and C. However, there is some evidence to show that mebendazole polymorph C is the only form effective against the soil-transmitted helminths. This protocol describes a stratified, randomized, placebo-controlled trial that examined the efficacy of different mebendazole polymorphs produced by the SPMC in the treatment of hookworm infections.

Clinical Details

Official title: Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Cure Rate

Secondary outcome:

Faecal Egg Count Reduction 1 (FECR1)

Faecal Egg Count Reduction 2 (FECR2)

Detailed description: Mebendazole has three polymorphic forms, identified as A, B and C. All of them are in accord with the US Pharmacopeia specifications (USP XXI) but they have distinct physiochemical characteristics (Himmelreich et al, 1977) and different therapeutic activities in experimentally infected mice with Trichinella spiralis infections (Rodriguez-Caabeiro et al, 1987). The original mebendazole tablets which were used to treat human infections had more than 90% of polymorph C (Van den Bossche et al, 1982), but most pharmacopeias currently do not specify the proportion of polymorph C that a tablet of mebendazole should contain, and the assay specified for measurement of the active ingredient measures all polymorphs together. There is some evidence to show that unlike polymorph C, polymorph A is ineffective in the treatment of hookworm and whipworm infections (Charoenlarp et al, 1993). The State Pharmaceutical Manufacturing Corporation of Sri Lanka produces both 500 mg and 100 mg tablets of mebendazole according to specifications laid down in the US Pharmacopeia. These tablets contain a mixture of polymorphs A and C. It is possible that increasing the content of mebendazole polymorph C in single dose tablets may improve cure rates and egg reduction rates, especially against hookworm and whipworm infections, where much variation in efficacy has been observed.

Eligibility

Minimum age: 3 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Necator americanus infection, as determined by examination of a single faecal smear,

alone or with Ascaris lumbricoides or Trichuris trichiura Exclusion Criteria:

- Children below the age of 2 years

- Pregnant women

- Individuals with diarrhea on day of treatment

Locations and Contacts

Agalawatta Plantations PLC, Nivitigala, Sabragamuwa, Sri Lanka

Lellopitiya Estate, Hapugastenne Plantations PLC, Ratnapura, Sabragamuwa, Sri Lanka

Additional Information

Starting date: May 2011
Last updated: April 18, 2013

Page last updated: August 23, 2015

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