CHEW_MEB_PEMBA: Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

• Sponsor: Swiss Tropical & Public Health Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03995680
• Collaborator: Public Health Laboratory Ivo de Carneri (Other)
• Enrollment: 397
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 135.8

Study Details

Study Description

Brief Summary

The rational of this study is to provide evidence on the safety and efficacy of a new chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged children infected with hookworm.

Condition or Disease	Intervention/Treatment	Phase
Hookworm Infections	Drug: Mebendazole	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 397 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of a New Chewable Tablet of Mebendazole Versus the Swallowable, Standard Tablet of Mebendazole Against Hookworm Infections in Children: a Randomized Controlled Trial
• Actual Study Start Date: Jul 12, 2019
• Actual Primary Completion Date: Oct 9, 2019
• Actual Study Completion Date: Oct 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chewable tablet of mebendazole 3-5 year olds allocated to the swallowable tablet arm will be given the crushed tablet on a spoon mixed with a small amount of clean water; 6-12 year olds allocated to the swallowable tablet arm will be given the whole tablet to swallow with a glass of clean water;	Drug: 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.
Active Comparator: Swallowable tablet of mebendazole 3-5 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and swallow it without water; if they cannot chew it then a small amount of water will be added to the tablet in a spoon; 6-12 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and then swallow it without water.	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm [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).

Secondary Outcome Measures

1. Cure Rate (CR) of Mebendazole Against Hookworm [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.

2. CR of Both Mebendazole Regimens Against Trichuris Trichiura [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.

3. Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura [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).

4. CR of Both Mebendazole Formulations Against Ascaris Lumbricoides [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.

5. Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides. [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).

6. Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm [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).

7. Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura [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).

8. Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female children aged between 3 and 12 years;

• Written informed consent signed by caregiver;

• Was examined by a study physician before treatment;

• Provided two stool samples at baseline;

• Hookworm EPG > 100 and at least two Kato-Katz thick smears slides with more than one hookworm egg;

Exclusion Criteria:

• Pregnant;

• Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, such as can upon initial clinical assessment;

• Suffers from severe anemia (Hb < 80 g/l);

• Received anthelminthic treatment or metronidazole within past four weeks.

• Attending other clinical trials during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Public Health Laboratory Ivo de Carneri	Chake Chake		Tanzania

Sponsors and Collaborators

• Swiss Tropical & Public Health Institute
• Public Health Laboratory Ivo de Carneri

Investigators

• Principal Investigator: Jennifer Keiser, PhD, Swiss Tropical & Public Health Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 26, 2019
• Informed Consent Form - Dec 24, 2018

More Information

Publications

None provided.

• Responsible Party: Jennifer Keiser, Prof. Dr., Swiss Tropical & Public Health Institute
• ClinicalTrials.gov Identifier: NCT03995680
• Other Study ID Numbers: CHEW_MEB
• First Posted: Jun 24, 2019
• Last Update Posted: Jul 20, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Jennifer Keiser, Prof. Dr., Swiss Tropical & Public Health Institute: Mebendazole; Chewable tablet; Hookworm; Soil-transmitted helminths; Efficacy; Safety; Acceptability
• Additional relevant MeSH terms: Infections; Hookworm Infections; Ancylostomiasis; Mebendazole; Piperazine; Piperazine citrate; DMP 777

Study Results

Participant Flow

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	199	198
COMPLETED	197	196
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	197	196	393
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.3 (2.0)	9.4 (2.1)	9.3 (2.1)
Sex: Female, Male (Count of Participants)
Female	87 44.2%	80 40.8%	167 42.5%
Male	110 55.8%	116 59.2%	226 57.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	130.5 (11.5)	130.8 (11.6)	130.7 (11.6)
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	25.4 (6.3)	26.0 (6.6)	25.7 (6.5)
Hemoglobin (grams per liter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [grams per liter]	121.5 (10.3)	123.5 (10.7)	122.5 (10.5)

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm
Description	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).
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	198
Number (95% Confidence Interval) [percentage change in hookworm egg counts]	68.5	70.8

2. Secondary Outcome

Title	Cure Rate (CR) of Mebendazole Against Hookworm
Description	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	196
Number (95% Confidence Interval) [percentage of participants]	12.7 6.4%	11.2 5.7%

3. Secondary Outcome

Title	CR of Both Mebendazole Regimens Against Trichuris Trichiura
Description	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	196
Number [percentage of participants]	9.8 5%	7.3 3.7%

4. Secondary Outcome

Title	Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura
Description	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).
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	196
Number (95% Confidence Interval) [percentage change in T. trich egg counts]	73.3	74.2

5. Secondary Outcome

Title	CR of Both Mebendazole Formulations Against Ascaris Lumbricoides
Description	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	196
Number [percentage of participants]	95.3 48.4%	97.8 49.9%

6. Secondary Outcome

Title	Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.
Description	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).
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	196
Number [percentage change in A. lumbr egg counts]	99.9	99.9

7. Secondary Outcome

Title	Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm
Description	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).
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	196
Number (95% Confidence Interval) [percentage change in hookworm egg counts]	38.2	28.1

8. Secondary Outcome

Title	Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura
Description	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).
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	196
Number [percentage change in T. trich egg counts]	52.9	50.9

9. Secondary Outcome

Title	Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides
Description	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).
Time Frame	Baseline (before treatment) and sometime between 14 and 21 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chewable Tablet of Mebendazole	Swallowable Tablet of Mebendazole
Arm/Group Description	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.	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.
Measure Participants	197	196
Number [percentage change in A. lumbr egg counts]	98.7	99.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chewable Tablet of Mebendazole, Swallowable Tablet of Mebendazole
	Comments	The 95% confidence intervals (CIs) for ERRs and the difference between ERRs were estimated via bootstrap resampling. Superiority was claimed if the 95% confidence interval of the difference in ERRs did not include unity. Logistic regression models were used to assess efficacy in terms of CRs. In a subsequent analysis an adjusted logistic regression (adjustment for age, sex, weight and baseline infection intensity) was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Egg Reduction Rate (%)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; -7.8 to 12.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	3 hours and 24 hours post-treatment
Adverse Event Reporting Description	Physicians and nurses actively questioned each child for adverse events using a questionnaire
Arm/Group Title	Chewable Tablet of Mebendazole		Swallowable Tablet of Mebendazole
Arm/Group Description	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.		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.
All Cause Mortality
	Chewable Tablet of Mebendazole		Swallowable Tablet of Mebendazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/197 (0%)		0/196 (0%)
Serious Adverse Events
	Chewable Tablet of Mebendazole		Swallowable Tablet of Mebendazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/197 (0%)		0/196 (0%)
Other (Not Including Serious) Adverse Events
	Chewable Tablet of Mebendazole		Swallowable Tablet of Mebendazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/197 (7.1%)		15/196 (7.7%)
General disorders
Abdominal pain	14/197 (7.1%)		15/196 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.