Trial · NCT03995680
Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
NCT03995680, Phase 2, Completed, Swiss Tropical & Public Health Institute; results first posted 2020-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm. Trials, record NCT03995680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03995680
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
- NCT number
- NCT03995680
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 397 participants, actual
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Conditions
- Hookworm Infections
- Interventions
- Mebendazole
- First posted
- 2019-06-24
- Last updated
- 2020-07-20
- Results first posted
- 2020-07-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | percentage change in hookworm egg counts | NUMBER | |
| SECONDARY | Cure Rate (CR) of Mebendazole Against Hookworm | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | percentage of participants | NUMBER | |
| SECONDARY | CR of Both Mebendazole Regimens Against Trichuris Trichiura | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | percentage of participants | NUMBER | |
| SECONDARY | Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | percentage change in T. trich egg counts | NUMBER | |
| SECONDARY | CR of Both Mebendazole Formulations Against Ascaris Lumbricoides | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | percentage of participants | NUMBER | |
| SECONDARY | Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides. | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | percentage change in A. lumbr egg counts | NUMBER | |
| SECONDARY | Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | percentage change in hookworm egg counts | NUMBER | |
| SECONDARY | Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | percentage change in T. trich egg counts | NUMBER | |
| SECONDARY | Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides | Baseline (before treatment) and sometime between 14 and 21 days post-treatment | percentage change in A. lumbr egg counts | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm | Chewable Tablet of Mebendazole | 68.5 | 95% Confidence Interval 60.4 to 75.3 | percentage change in hookworm egg counts | |
| Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm | Swallowable Tablet of Mebendazole | 70.8 | 95% Confidence Interval 63.5 to 76.7 | percentage change in hookworm egg counts | |
| Cure Rate (CR) of Mebendazole Against Hookworm | Chewable Tablet of Mebendazole | 12.7 | 95% Confidence Interval 8.4 to 18.2 | percentage of participants | |
| Cure Rate (CR) of Mebendazole Against Hookworm | Swallowable Tablet of Mebendazole | 11.2 | 95% Confidence Interval 7.2 to 16.5 | percentage of participants | |
| CR of Both Mebendazole Regimens Against Trichuris Trichiura | Chewable Tablet of Mebendazole | 9.8 | percentage of participants | ||
| CR of Both Mebendazole Regimens Against Trichuris Trichiura | Swallowable Tablet of Mebendazole | 7.3 | percentage of participants | ||
| Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura | Chewable Tablet of Mebendazole | 73.3 | 95% Confidence Interval 65.7 to 79.4 | percentage change in T. trich egg counts | |
| Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura | Swallowable Tablet of Mebendazole | 74.2 | 95% Confidence Interval 67.2 to 79.8 | percentage change in T. trich egg counts | |
| CR of Both Mebendazole Formulations Against Ascaris Lumbricoides | Chewable Tablet of Mebendazole | 95.3 | percentage of participants | ||
| CR of Both Mebendazole Formulations Against Ascaris Lumbricoides | Swallowable Tablet of Mebendazole | 97.8 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chewable Tablet of Mebendazole | 199 | |
| Overall Study | STARTED | Swallowable Tablet of Mebendazole | 198 | |
| Overall Study | COMPLETED | Chewable Tablet of Mebendazole | 197 | |
| Overall Study | COMPLETED | Swallowable Tablet of Mebendazole | 196 | |
| Overall Study | NOT COMPLETED | Chewable Tablet of Mebendazole | 2 | |
| Overall Study | NOT COMPLETED | Swallowable Tablet of Mebendazole | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | General disorders | Chewable Tablet of Mebendazole | 14 | 197 | |
| other | Abdominal pain | General disorders | Swallowable Tablet of Mebendazole | 15 | 196 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chewable Tablet of Mebendazole | 0 | 197 |
| Total, all-cause mortality | Swallowable Tablet of Mebendazole | 0 | 196 |
| Total, other adverse events | Chewable Tablet of Mebendazole | 14 | 197 |
| Total, other adverse events | Swallowable Tablet of Mebendazole | 15 | 196 |
| Total, serious adverse events | Chewable Tablet of Mebendazole | 0 | 197 |
| Total, serious adverse events | Swallowable Tablet of Mebendazole | 0 | 196 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33150325 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chewable Tablet of Mebendazole vs Swallowable Tablet of Mebendazole: deaths from any cause | Trial comparisons |
| Chewable Tablet of Mebendazole vs Swallowable Tablet of Mebendazole: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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