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| ID | Type | Description | Link |
|---|---|---|---|
| Ragama ERC | Registry Identifier | www.clinicaltrials.org |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka |
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| Mebendazole polymorph A and C 500 mg | Active Comparator | 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 |
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| Mebendazole polymorph C 500 mg | Experimental | Mebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mebendazole polymorph A and C 500 mg | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cure Rate | Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100 | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal Egg Count Reduction 1 (FECR1) | FECR1= {[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)]÷(arithmetic mean of pretreatment egg counts)}×100 | Two weeks |
| Faecal Egg Count Reduction 2 (FECR2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilanthi R de Silva, MD | Faculty of Medicine, University of Kelaniya, Sri Lanka | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agalawatta Plantations PLC | Nivithigala | Sabragamuwa | Sri Lanka | |||
| Lellopitiya Estate, Hapugastenne Plantations PLC |
Infants below the age of 2 years, pregnant women, and those with diarrhoea on the day of recruitment were excluded from the study.
In order to identify those with hookworm infections, all individuals living in 219 households, in 8 estate divisions in Ratnapura District known to have a high prevalence of hookworm, were recruited to the study after obtaining their written, informed consent. Each person was requested to provide one faecal sample.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 70 were allocated to this arm and 49 were followed up in the post treatment. |
| FG001 | Mebendazole Polymorph A and C 500 mg | 70 were allocated and 53 were followed up in the post treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Mebendazole polymorph C | Drug | Mebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone |
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| Placebo | Drug | Placebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka |
|
FECR2=〈Arithmetic mean {[(pretreatment egg count)-(posttreatment egg count)]÷(pretreatment egg count)}〉×100
| Two weeks |
| Ratnapura |
| Sabragamuwa |
| Sri Lanka |
| FG002 | Mebendazole Polymorph C 500 mg | 74 were allocated and 48 were followed up in the post treatment. |
| COMPLETED |
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| NOT COMPLETED |
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All those found positive for hookworm infection, from among the population screened at baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Hookworm positive participants randomized to placebo |
| BG001 | Mebendazole Polymorph A and C 500 mg | Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg |
| BG002 | Mebendazole Polymorph C 500 mg | Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cure Rate | Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100 | All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up. | Posted | Number | percentage of participants | Two weeks |
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| Secondary | Faecal Egg Count Reduction 1 (FECR1) | FECR1= {[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)]÷(arithmetic mean of pretreatment egg counts)}×100 | All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow-up, were included in the analysis | Posted | Number | percentage of eggs excreted | Two weeks |
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| Secondary | Faecal Egg Count Reduction 2 (FECR2) | FECR2=〈Arithmetic mean {[(pretreatment egg count)-(posttreatment egg count)]÷(pretreatment egg count)}〉×100 | All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up were included in the analysis | Posted | Mean | Standard Deviation | percentage of eggs excreted | Two weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Hookworm positive participants randomized to placebo | 0 | 70 | 0 | 70 | ||
| EG001 | Mebendazole Polymorph A and C 500 mg | Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg | 0 | 70 | 0 | 70 | ||
| EG002 | Mebendazole Polymorph C 500 mg | Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg | 0 | 74 | 0 | 74 |
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Small sample size owing to limitation in available funds.
Release after two years after completing trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Balachandran Kumarendran | University of Kelaniya | 0094112961140 | drbkumaran@gmail.com |
| ID | Term |
|---|---|
| D000724 | Ancylostomiasis |
| ID | Term |
|---|---|
| D006725 | Hookworm Infections |
| D017206 | Strongylida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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