Phase 3
Completed N=214
Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
Necator Americanus Infection
Source: ClinicalTrials.gov NCT01350271 ↗
Enrolled (actual)
214
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Cure Rate — 16.3; 28.3; 18.8 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate |
16.3; 28.3; 18.8 | — |
| SECONDARY Faecal Egg Count Reduction 1 (FECR1) |
-6.6; 86.1; 84.5 | — |
| SECONDARY Faecal Egg Count Reduction 2 (FECR2) |
-108.1; 66.2; 49.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT01350271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.