Trial Outcomes & Findings for Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm (NCT NCT03995680)

NCT ID: NCT03995680

Last Updated: 2020-07-20

Results Overview

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 397 participants
• Primary outcome timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
• Results posted on: 2020-07-20

Participant Flow

Participant milestones

Measure	Chewable Tablet of Mebendazole A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Overall Study STARTED	199	198
Overall Study COMPLETED	197	196
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Total n=393 Participants Total of all reporting groups
Age, Continuous	9.3 years STANDARD_DEVIATION 2.0 • n=197 Participants	9.4 years STANDARD_DEVIATION 2.1 • n=196 Participants	9.3 years STANDARD_DEVIATION 2.1 • n=393 Participants
Sex: Female, Male Female	87 Participants n=197 Participants	80 Participants n=196 Participants	167 Participants n=393 Participants
Sex: Female, Male Male	110 Participants n=197 Participants	116 Participants n=196 Participants	226 Participants n=393 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	130.5 centimeters STANDARD_DEVIATION 11.5 • n=197 Participants	130.8 centimeters STANDARD_DEVIATION 11.6 • n=196 Participants	130.7 centimeters STANDARD_DEVIATION 11.6 • n=393 Participants
Weight	25.4 kilograms STANDARD_DEVIATION 6.3 • n=197 Participants	26.0 kilograms STANDARD_DEVIATION 6.6 • n=196 Participants	25.7 kilograms STANDARD_DEVIATION 6.5 • n=393 Participants
Hemoglobin	121.5 grams per liter STANDARD_DEVIATION 10.3 • n=197 Participants	123.5 grams per liter STANDARD_DEVIATION 10.7 • n=196 Participants	122.5 grams per liter STANDARD_DEVIATION 10.5 • n=393 Participants

PRIMARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=198 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm	68.5 percentage change in hookworm egg counts Interval 60.4 to 75.3	70.8 percentage change in hookworm egg counts Interval 63.5 to 76.7

SECONDARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Cure Rate (CR) of Mebendazole Against Hookworm	12.7 percentage of participants Interval 8.4 to 18.2	11.2 percentage of participants Interval 7.2 to 16.5

SECONDARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
CR of Both Mebendazole Regimens Against Trichuris Trichiura	9.8 percentage of participants	7.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura	73.3 percentage change in T. trich egg counts Interval 65.7 to 79.4	74.2 percentage change in T. trich egg counts Interval 67.2 to 79.8

SECONDARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
CR of Both Mebendazole Formulations Against Ascaris Lumbricoides	95.3 percentage of participants	97.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.	99.9 percentage change in A. lumbr egg counts	99.9 percentage change in A. lumbr egg counts

SECONDARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100).

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm	38.2 percentage change in hookworm egg counts Interval 26.6 to 47.8	28.1 percentage change in hookworm egg counts Interval 8.5 to 44.3

SECONDARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100).

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura	52.9 percentage change in T. trich egg counts	50.9 percentage change in T. trich egg counts

SECONDARY outcome

Timeframe: Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100).

Outcome measures

Measure	Chewable Tablet of Mebendazole n=197 Participants A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 Participants A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides	98.7 percentage change in A. lumbr egg counts	99.8 percentage change in A. lumbr egg counts

Adverse Events

Chewable Tablet of Mebendazole

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Swallowable Tablet of Mebendazole

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chewable Tablet of Mebendazole n=197 participants at risk A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	Swallowable Tablet of Mebendazole n=196 participants at risk A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
General disorders Abdominal pain	7.1% 14/197 • 3 hours and 24 hours post-treatment Physicians and nurses actively questioned each child for adverse events using a questionnaire	7.7% 15/196 • 3 hours and 24 hours post-treatment Physicians and nurses actively questioned each child for adverse events using a questionnaire

Additional Information

Dr. Jennifer Keiser

Swiss Tropical and Public Health Institute

Phone: +41612848218

Email: jennifer.keiser@swisstph.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place