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

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ClinicalTrials.gov Identifier: NCT01350271
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : April 22, 2013
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
N R de Silva, University of Kelaniya

Study Description
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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.

Condition or disease Intervention/treatment Phase
Necator Americanus Infection Drug: Mebendazole polymorph A and C 500 mg Drug: Mebendazole polymorph C Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Mebendazole

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka
 Drug: Placebo
Placebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka
Active Comparator: Mebendazole polymorph A and C 500 mg
Mebendazole tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg of mebendazole as a 50:50 mixture of Polymorphs A and C
 Drug: Mebendazole polymorph A and C 500 mg
Mebendazole tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg of mebendazole as a 50:50 mixture of Polymorphs A and C
Other Name: Lot FG10M01
Experimental: Mebendazole polymorph C 500 mg
Mebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone
 Drug: Mebendazole polymorph C
Mebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone
Other Name: Lot FG10H01


Outcome Measures
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Primary Outcome Measures :
  1. Cure Rate [ Time Frame: Two weeks ]
    Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100


Secondary Outcome Measures :
  1. Faecal Egg Count Reduction 1 (FECR1) [ Time Frame: Two weeks ]
    FECR1= {[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)]÷(arithmetic mean of pretreatment egg counts)}×100

  2. Faecal Egg Count Reduction 2 (FECR2) [ Time Frame: Two weeks ]
    FECR2=〈Arithmetic mean {[(pretreatment egg count)-(posttreatment egg count)]÷(pretreatment egg count)}〉×100


Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350271


Locations
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Sri Lanka
Agalawatta Plantations PLC
Nivitigala, Sabragamuwa, Sri Lanka
Lellopitiya Estate, Hapugastenne Plantations PLC
Ratnapura, Sabragamuwa, Sri Lanka
Sponsors and Collaborators
University of Kelaniya
Investigators
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Principal Investigator: Nilanthi R de Silva, MD Faculty of Medicine, University of Kelaniya, Sri Lanka
More Information
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Responsible Party: N R de Silva, Professor of Parasitology, University of Kelaniya
ClinicalTrials.gov Identifier: NCT01350271    
Other Study ID Numbers: P39/04/2010
Ragama ERC ( Registry Identifier: www.clinicaltrials.org )
First Posted: May 9, 2011    Key Record Dates
Results First Posted: April 22, 2013
Last Update Posted: April 22, 2013
Last Verified: April 2013
Keywords provided by N R de Silva, University of Kelaniya:
Hookworm
Necator americanus
Mebendazole
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Helminthiasis
Disease Attributes
Pathologic Processes
Parasitic Diseases
Mebendazole
Piperazine
Piperazine citrate
DMP 777
 Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors