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
|