Trial Outcomes & Findings for Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections (NCT NCT01350271)

Results Overview

Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

214 participants

Primary outcome timeframe

Two weeks

Results posted on

2013-04-22

Participant Flow

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.

Infants below the age of 2 years, pregnant women, and those with diarrhoea on the day of recruitment were excluded from the study.

Participant milestones

Participant milestones
Measure	Placebo 70 were allocated to this arm and 49 were followed up in the post treatment.	Mebendazole Polymorph A and C 500 mg 70 were allocated and 53 were followed up in the post treatment.	Mebendazole Polymorph C 500 mg 74 were allocated and 48 were followed up in the post treatment.
Overall Study STARTED	70	70	74
Overall Study COMPLETED	49	53	48
Overall Study NOT COMPLETED	21	17	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 70 were allocated to this arm and 49 were followed up in the post treatment.	Mebendazole Polymorph A and C 500 mg 70 were allocated and 53 were followed up in the post treatment.	Mebendazole Polymorph C 500 mg 74 were allocated and 48 were followed up in the post treatment.
Overall Study Lost to Follow-up	21	17	26

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=70 Participants Hookworm positive participants randomized to placebo	Mebendazole Polymorph A and C 500 mg n=70 Participants Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg	Mebendazole Polymorph C 500 mg n=74 Participants Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg	Total n=214 Participants Total of all reporting groups
Age, Categorical <=18 years	17 Participants n=5 Participants	18 Participants n=7 Participants	23 Participants n=5 Participants	58 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	48 Participants n=7 Participants	47 Participants n=5 Participants	144 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Age Continuous	34 years STANDARD_DEVIATION 18 • n=5 Participants	36 years STANDARD_DEVIATION 19 • n=7 Participants	32 years STANDARD_DEVIATION 18 • n=5 Participants	34 years STANDARD_DEVIATION 18 • n=4 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	40 Participants n=5 Participants	114 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	33 Participants n=7 Participants	34 Participants n=5 Participants	100 Participants n=4 Participants
Region of Enrollment Sri Lanka	70 participants n=5 Participants	70 participants n=7 Participants	74 participants n=5 Participants	214 participants n=4 Participants

PRIMARY outcome

Timeframe: Two weeks

Population: All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up.

Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Hookworm infected individual randomized to placebo	Mebendazole Polymorph A and C 500 mg n=53 Participants Hookworm infected individuals randomized to a single dose of Mebendazole polymorph A and C 500 mg	Mebendazole Polymorph C 500 mg n=48 Participants Hookworm infected individuals randomized to a single dose of Mebendazole polymorph C 500 mg
Cure Rate	16.3 percentage of participants	28.3 percentage of participants	18.8 percentage of participants

SECONDARY outcome

Timeframe: Two weeks

Population: All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow-up, were included in the analysis

FECR1= {\[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)\]÷(arithmetic mean of pretreatment egg counts)}×100

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Hookworm infected individual randomized to placebo	Mebendazole Polymorph A and C 500 mg n=53 Participants Hookworm infected individuals randomized to a single dose of Mebendazole polymorph A and C 500 mg	Mebendazole Polymorph C 500 mg n=48 Participants Hookworm infected individuals randomized to a single dose of Mebendazole polymorph C 500 mg
Faecal Egg Count Reduction 1 (FECR1)	-6.6 percentage of eggs excreted	86.1 percentage of eggs excreted	84.5 percentage of eggs excreted

SECONDARY outcome

Timeframe: Two weeks

Population: All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up were included in the analysis

FECR2=〈Arithmetic mean {\[(pretreatment egg count)-(posttreatment egg count)\]÷(pretreatment egg count)}〉×100

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Hookworm infected individual randomized to placebo	Mebendazole Polymorph A and C 500 mg n=53 Participants Hookworm infected individuals randomized to a single dose of Mebendazole polymorph A and C 500 mg	Mebendazole Polymorph C 500 mg n=48 Participants Hookworm infected individuals randomized to a single dose of Mebendazole polymorph C 500 mg
Faecal Egg Count Reduction 2 (FECR2)	-108.1 percentage of eggs excreted Standard Deviation 557.5	66.2 percentage of eggs excreted Standard Deviation 42.5	49.8 percentage of eggs excreted Standard Deviation 82.6

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mebendazole Polymorph A and C 500 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mebendazole Polymorph C 500 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Balachandran Kumarendran

University of Kelaniya

Phone: 0094112961140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Release after two years after completing trial
Publication restrictions are in place

Restriction type: OTHER