Clinical trial NCT01350271: Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
Official title: Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Necator Americanus Infection
Keywords: Hookworm
Necator americanus
Mebendazole
Lead sponsor: University of Kelaniya
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 214
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Cure Rate
timeFrame: Two weeks
Secondary outcomes:
measure: Faecal Egg Count Reduction 1 (FECR1)
timeFrame: Two weeks
measure: Faecal Egg Count Reduction 2 (FECR2)
timeFrame: Two weeks
Other outcomes:
Locations:
city: Nivitigala
country: Sri Lanka
facility: Agalawatta Plantations PLC
state: Sabragamuwa
city: Ratnapura
country: Sri Lanka
facility: Lellopitiya Estate, Hapugastenne Plantations PLC
state: Sabragamuwa
Study officials:
affiliation: Faculty of Medicine, University of Kelaniya, Sri Lanka
name: Nilanthi R de Silva, MD
role: PRINCIPAL_INVESTIGATOR
References: