Trial · NCT04726969
Efficacy and Safety of MOX/ALB Co-administration
NCT04726969, Phase 3, Completed, Jennifer Keiser; results first posted 2023-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of MOX/ALB Co-administration. Trials, record NCT04726969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04726969
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of MOX/ALB Co-administration
- NCT number
- NCT04726969
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 255 participants, actual
- Lead sponsor
- Jennifer Keiser
- Conditions
- Trichuriasis, Ascariasis, Hookworm Infections
- Interventions
- Moxidectin 2 mg Oral Tablet, Albendazole 400 mg Oral Tablet, Ivermectin 3 mg Oral Tablet
- First posted
- 2021-01-27
- Last updated
- 2024-01-24
- Results first posted
- 2023-02-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 14-21 days after treatment | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. |
| Secondary | Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 14-21 days after 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. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 14-21 days after treatment | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. |
| Secondary | Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 14-21 days after 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. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | 14-21 days after treatment | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. |
| Secondary | Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | 14-21 days after 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. Geometric and arithmetic mean egg counts will be calculated for the three treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | 14-21 days after treatment | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. |
| Secondary | Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | 14-21 days after 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. Geometric and arithmetic mean egg counts will be calculated for the three treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Number of Participants Reporting Adverse Events (AEs) | 3 hours, 24 hours and 14-21 days after treatment | Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs. |
| Other | Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years) | 0 to 24 hours after treatment | For characterization of population pharmacokinetics (PK) and drug-drug interaction parameters ivermectin, albendazole and its metabolites will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a lower limit of quantification of 1-5 ng/ml. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 14-21 days after treatment | Available case analysis | percentage of participants (%) | NUMBER |
| SECONDARY | Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 14-21 days after treatment | percent change | GEOMETRIC_MEAN | |
| SECONDARY | Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 14-21 days after treatment | percentage of participants (%) | NUMBER | |
| SECONDARY | Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 14-21 days after treatment | percent change | MEAN | |
| SECONDARY | Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | 14-21 days after treatment | Available case analysis | percentage of participants (%) | NUMBER |
| SECONDARY | Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | 14-21 days after treatment | Available case analysis | percent change | MEAN |
| SECONDARY | Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | 14-21 days after treatment | Available case analysis | percentage of participants (%) | NUMBER |
| SECONDARY | Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | 14-21 days after treatment | Available case analysis | percent change | MEAN |
| SECONDARY | Number of Participants Reporting Adverse Events (AEs) | 3 hours, 24 hours and 14-21 days after treatment | Analysis population at 3 hours after drug administration: N=255 Analysis population at 24 hours after drug administration: N=250 Analysis population at 14-21 days after drug administration: N=210 | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years) | 0 to 24 hours after treatment | Arm B did not receive ivermectin, thus no concentration was measured. | ng/ml | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group89
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Arm A: Moxidectin and Albendazole | 15.3 | 95% Confidence Interval 7.9 to 25.7 | percentage of participants (%) | |
| Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Arm B: Albendazole | 13.4 | 95% Confidence Interval 6.3 to 24.0 | percentage of participants (%) | |
| Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Arm A: Moxidectin and Albendazole | 67.0 | 95% Confidence Interval 47.8 to 80.1 | percent change | |
| Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Arm B: Albendazole | 60.2 | 95% Confidence Interval 35.7 to 76.5 | percent change | |
| Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Arm B: Albendazole | 13.4 | 95% Confidence Interval 6.3 to 24.0 | percentage of participants (%) | |
| Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Arm C: Ivermectin and Albendazole | 22.5 | 95% Confidence Interval 13.5 to 34.0 | percentage of participants (%) | |
| Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Arm B: Albendazole | 60.2 | 95% Confidence Interval 35.7 to 76.5 | percent change | |
| Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Arm C: Ivermectin and Albendazole | 81.5 | 95% Confidence Interval 68.8 to 89.1 | percent change | |
| Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | Arm A: Moxidectin and Albendazole | 95.5 | 95% Confidence Interval 86.0 to 100 | percentage of participants (%) | |
| Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | Arm B: Albendazole | 95.5 | 95% Confidence Interval 86.0 to 100 | percentage of participants (%) |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Moxidectin and Albendazole | 85 | |
| Overall Study | STARTED | Arm B: Albendazole | 84 | |
| Overall Study | STARTED | Arm C: Ivermectin and Albendazole | 86 | |
| Overall Study | COMPLETED | Arm A: Moxidectin and Albendazole | 72 | |
| Overall Study | COMPLETED | Arm B: Albendazole | 67 | |
| Overall Study | COMPLETED | Arm C: Ivermectin and Albendazole | 71 | |
| Overall Study | NOT COMPLETED | Arm A: Moxidectin and Albendazole | 13 | |
| Overall Study | NOT COMPLETED | Arm B: Albendazole | 17 | |
| Overall Study | NOT COMPLETED | Arm C: Ivermectin and Albendazole | 15 |
Source ClinicalTrials.gov
Adverse events21
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 | Headache | General disorders | Arm A: Moxidectin and Albendazole | 4 | 85 | 5 |
| other | Headache | General disorders | Arm B: Albendazole | 12 | 84 | 14 |
| other | Headache | General disorders | Arm C: Ivermectin and Albendazole | 12 | 86 | 13 |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: Moxidectin and Albendazole | 11 | 85 | 12 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: Albendazole | 10 | 84 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | Arm C: Ivermectin and Albendazole | 18 | 86 | 20 |
| other | Nausea | General disorders | Arm A: Moxidectin and Albendazole | 4 | 85 | 4 |
| other | Nausea | General disorders | Arm B: Albendazole | 2 | 84 | 2 |
| other | Nausea | General disorders | Arm C: Ivermectin and Albendazole | 5 | 86 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Arm A: Moxidectin and Albendazole | 6 | 85 | 7 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Moxidectin and Albendazole | 0 | 85 |
| Total, all-cause mortality | Arm B: Albendazole | 0 | 84 |
| Total, all-cause mortality | Arm C: Ivermectin and Albendazole | 0 | 86 |
| Total, other adverse events | Arm A: Moxidectin and Albendazole | 31 | 85 |
| Total, other adverse events | Arm B: Albendazole | 26 | 84 |
| Total, other adverse events | Arm C: Ivermectin and Albendazole | 34 | 86 |
| Total, serious adverse events | Arm A: Moxidectin and Albendazole | 0 | 85 |
| Total, serious adverse events | Arm B: Albendazole | 0 | 84 |
| Total, serious adverse events | Arm C: Ivermectin and Albendazole | 0 | 86 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37357904 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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