This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Efficacy and Safety of MOX/ALB Co-administration (NCT04726969), a randomized phase 3 study. The primary outcome is Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04726969 |
| Phase | Phase 3 |
| Condition | Trichuriasis, Ascariasis, Hookworm Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 255 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Jennifer Keiser |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled adolescents and adults with Trichuris trichiura infection in Côte d'Ivoire. The study summary describes the age range as 12-60 years and the primary outcome as applying to participants who were egg-positive before treatment. The registry also lists ascariasis and hookworm infections among the conditions studied, including outcomes for participants with co-infections.
Intervention
The primary comparison concerns moxidectin combined with albendazole. The regimen is described as oral moxidectin 8 mg, given as 4 tablets of 2 mg, together with 1 tablet of albendazole 400 mg on day 0.
Comparator
The comparator is albendazole alone: 1 tablet of albendazole 400 mg on day 0, accompanied by placebo for moxidectin, described as 4 tablets. A separate arm received ivermectin with albendazole; that arm is not the comparator for the posted primary result.
Primary question
Among participants egg-positive for whipworm before treatment, what proportion became egg-negative 14-21 days after treatment in the moxidectin-and-albendazole arm, and how does that cure rate compare with albendazole alone? The posted estimates are 15.3% for the combination and 13.4% for albendazole alone. Their confidence intervals are 7.9% to 25.7% and 6.3% to 24.0%, respectively.
3. Trial Design
The registry describes a completed, phase 3, randomized, parallel-group trial with quadruple masking. Its title identifies three treatment approaches: moxidectin plus albendazole, ivermectin plus albendazole, and albendazole alone. The study summary calls the trial double-blind, while the design fields state quadruple masking; the registry record does not explain the difference in those descriptions.
The reported enrollment is 255. That is the registry's enrollment figure, not the number included in the primary available-case analysis. The primary result includes 72 participants in the moxidectin-and-albendazole arm and 67 in the albendazole-alone arm. The registry gives the primary analysis population as available case analysis, so the reported arm sizes should be understood as the participants contributing to this outcome rather than assumed to represent every enrolled participant.
Treatment was administered orally on day 0. The primary endpoint was assessed 14-21 days after treatment. The record lists additional outcomes for egg reduction and cure against whipworm, outcomes for ascariasis and hookworm infections among co-infected participants, and adverse events. The posted primary result covers the comparison of moxidectin plus albendazole with albendazole alone. Although the ivermectin-and-albendazole arm is part of the trial, its primary-outcome estimate is not reported in the registry record.
The recorded start date is 2021-06-15, the primary completion date is 2021-09-09, and the study status is completed. The registry record does not report the method used to generate the random allocation sequence, how allocation was concealed, or which trial roles were masked. It also does not report a sample-size justification or a detailed statistical analysis plan.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| STARTED | 85 | 84 | 86 |
| COMPLETED | 72 | 67 | 71 |
| NOT COMPLETED | 13 | 17 | 15 |
Analysis population for the primary outcome, as defined in the registry: Available case analysis
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole | Total |
|---|---|---|---|---|---|
| Participants analysed | 85 | 84 | 86 | 255 | |
| Age, Categorical: <=18 years | Participants | 38 | 39 | 33 | 110 |
| Age, Categorical: Between 18 and 65 years | Participants | 47 | 45 | 53 | 145 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 30.1 (SD 16.1) | 26.7 (SD 14.5) | 29.9 (SD 15.4) | 28.9 (SD 15.4) |
| Sex: Female, Male: Female | Participants | 44 | 44 | 49 | 137 |
| Sex: Female, Male: Male | Participants | 41 | 40 | 37 | 118 |
| Race and Ethnicity Not Collected | Participants | — | — | — | 0 |
| Region of Enrollment: Côte D'Ivoire | Participants | 85 | 84 | 86 | 255 |
6. Primary Endpoint
The registry lists the primary outcome as Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura, measured over 14-21 days after treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants (%) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the cure rate for Trichuris trichiura, defined as the proportion of participants who were egg-positive before treatment and egg-negative after treatment, multiplied by 100. The registry specifies assessment 14-21 days after treatment. The analysis population is described as available case analysis.
This endpoint expresses treatment response as a percentage of participants meeting the stated egg-status definition. It is a categorical outcome: each assessed participant either meets the definition of cure or does not. The registry reports the proportion with a 95% confidence interval, which communicates uncertainty around the estimated cure rate. It does not give the individual participant data, the count of participants meeting the cure definition, or a separate denominator of baseline egg-positive participants for this outcome.
As a general statistical point, cure rate and egg reduction rate describe different aspects of response. Cure rate focuses on whether a participant crosses from egg-positive to egg-negative; egg reduction rate concerns change in egg counts. The registry lists egg reduction rate as a secondary outcome, but the posted primary endpoint is the cure-rate measure. A cure-rate estimate alone does not describe the amount of egg-count change among participants who remain egg-positive.
The endpoint is useful for a direct, clinically interpretable summary of the proportion meeting the study's stated parasitological definition at the specified follow-up. Its interpretation is limited to that definition, population, and assessment window; it should not be read as a measure of longer-term outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary cure-rate estimate is 15.3% in the moxidectin-and-albendazole arm, with a 95% confidence interval from 7.9% to 25.7%. The estimate for albendazole alone is 13.4%, with a 95% confidence interval from 6.3% to 24.0%. The point estimate is numerically higher in the combination arm, but the registry record does not report a direct comparative effect estimate, confidence interval for the difference, or p-value for this primary comparison. A numerical difference should not be calculated from these posted summaries as a substitute for the trial's own comparison.
The confidence intervals describe uncertainty in each arm's estimated cure rate. They span a range of values around the observed estimate, rather than identifying a single value as certain. The intervals are broad and overlap. Their overlap does not by itself establish whether the treatments differ, and separate arm-level intervals are not the same as an interval for the between-arm contrast. The registry record does not report a formal test or model for that contrast, so the posted figures alone do not support a definitive claim about comparative statistical evidence.
The primary analysis is identified as available case analysis. The arm sizes reported for this outcome are 72 and 67. The record does not explain how participants without an available post-treatment assessment were handled, how many were missing, or whether the analysis included every participant assigned to these arms. This matters because an available-case estimate describes participants with outcome data and may not represent all randomized participants if the availability of outcome data is related to their outcomes.
The trial also included an ivermectin-and-albendazole arm, but no result for that arm is included in the primary outcome values posted in the registry record. The primary comparison therefore should not be generalized to that regimen. Nor do the primary cure-rate estimates answer the secondary questions about egg reduction, other infections, or adverse events.
In general, randomized allocation is intended to support fair comparison of groups, while masking can limit some forms of bias. The record identifies randomization and quadruple masking, but it does not give enough detail to assess implementation. These features are relevant context, not proof that every possible source of bias was prevented. The estimates should be read as the observed registry results, with uncertainty and reporting gaps kept in view.
9. Statistical Methods Explained
What does the confidence interval communicate?
The primary outcome is a proportion expressed as a percentage, and the registry reports a 95% confidence interval for each arm. In general, a confidence interval describes the statistical uncertainty around an estimate under the method used to construct it. It is not a guarantee that the true value lies within the particular interval, nor does it mean that most individual participants have outcomes within that range. The reported intervals are 7.9% to 25.7% for moxidectin plus albendazole and 6.3% to 24.0% for albendazole alone.
These are arm-specific intervals. A comparison between treatments is usually assessed with an interval or test for a contrast, using an analysis that accounts for the trial design and the outcome data. The registry record does not report such a contrast or its uncertainty for the primary outcome. It is therefore not appropriate to treat the appearance or overlap of the arm-specific intervals as a formal comparison test. General statistical interpretation must distinguish descriptive estimates within each arm from evidence about the difference between arms.
Why does the analysis population matter?
The registry labels the primary population as available case analysis. In general, this means the calculation uses participants for whom the relevant outcome is available, rather than automatically including everyone randomized. The reported outcome group sizes are 72 for moxidectin plus albendazole and 67 for albendazole alone. The registry record does not report the amount or pattern of missing outcome data, nor does it describe imputation or sensitivity analyses. Without those details, readers cannot assess whether missing assessments could have influenced the estimates.
For a binary endpoint such as cure status, a proportion is formed from participants meeting the cure definition among those assessed and eligible under the analysis definition. The record defines cure as being egg-positive before treatment and egg-negative after treatment. It does not separately report the numerator and denominator used to produce each percentage. The published percentages should therefore be read as the recorded summary estimates, not reverse-engineered into participant counts.
What role do randomization and masking play?
In general, randomization aims to make treatment groups comparable with respect to factors known and unknown at the time of assignment. Masking can reduce the influence of treatment knowledge on participant behavior, clinical care, assessment, or analysis, depending on who is masked. This trial is described as randomized and quadruple-masked in the design fields. The study summary also describes it as double-blind. The registry record does not specify the allocation procedure, concealment process, or the people included in the masking description, so the practical implementation cannot be evaluated from the record alone.
The parallel-group structure means each participant is assigned to a treatment group rather than receiving a sequence of study treatments. The primary comparison is between the moxidectin-and-albendazole arm and the albendazole-alone arm. The separate ivermectin-and-albendazole arm provides another randomized treatment group, but its primary cure-rate result is not reported with these posted values. The result for the two reported arms should not be treated as an estimate for all three regimens.
What can be inferred from the reported analysis?
The registry reports arm-level cure rates and confidence intervals, but no primary comparative p-value, adjusted estimate, or analysis model. The number of analyses is recorded as 0. This does not establish that no analysis was conducted; it means a specific analysis result is not posted in the record's analysis listing. The registry record also does not report whether covariate adjustment, stratification, or a prespecified model was used.
As general guidance, an unadjusted recalculation from summary statistics would not replace a sponsor's own trial analysis where one is reported. In this record, no sponsor comparative analysis is posted for the primary outcome, and there is no stated discrepancy between posted and recalculated results. Consequently, the arm-level summaries support descriptive interpretation, but not a reconstructed confirmatory comparison.
The record identifies 13 outcome measures and lists 8 secondary outcomes as posted. Multiple outcomes can create multiplicity concerns when several hypotheses are tested, because the chance of at least one false-positive finding can increase across repeated tests. The registry record does not report a multiplicity adjustment or a hierarchy of testing. No secondary-outcome p-values or comparative estimates are included in the primary results, so their statistical evidence cannot be assessed from these data.
The trial's enrollment figure is 255. It is not a sample-size justification or evidence of statistical power for the primary comparison. The registry record does not report the assumptions used to choose enrollment, a target effect, or a planned power calculation. General sample-size planning uses assumptions about the effect to detect, outcome variability, significance level, allocation, and analysis approach; without the trial's design rationale, adequacy for a particular effect cannot be judged.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures and 8 posted secondary outcomes. These include egg reduction and cure outcomes for whipworm, cure and egg reduction outcomes for ascariasis and hookworm among co-infected participants, and adverse events. The primary cure-rate comparison is one question within a broader set of outcomes. When many outcomes are examined, general statistical practice considers multiplicity: repeated testing can increase the chance of a nominally notable result occurring by chance. The registry record does not report a multiplicity adjustment, outcome hierarchy, or strategy for interpreting multiple tests.
The primary analysis population is described as available case analysis. The record does not report how many participants lacked an assessment, reasons for missingness, or how missing outcomes were handled. It also does not describe sensitivity analyses comparing different assumptions about missing results. These omissions limit assessment of whether the reported cure rates could be affected by missing post-treatment data.
The registry reports no analyses in its analysis listing, and it does not post a comparative test or estimate for the primary contrast. The primary arm-level estimates and confidence intervals remain interpretable as descriptive summaries, but the record does not provide enough detail to reconstruct the inferential plan or determine how the multiple outcomes were handled in analysis.
The available-case population should not be conflated with all enrolled participants or assumed to be identical to every randomized participant. The record does not state whether analyses followed an intention-to-treat principle, whether any per-protocol analysis was performed, or how protocol deviations were treated. Those details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arm A: Moxidectin and Albendazole | 0 | 85 | 0.0% |
| Arm B: Albendazole | 0 | 84 | 0.0% |
| Arm C: Ivermectin and Albendazole | 0 | 86 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm A: Moxidectin and Albendazole | 0 of 85 |
| Arm B: Albendazole | 0 of 84 |
| Arm C: Ivermectin and Albendazole | 0 of 86 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Arm A: Moxidectin and Albendazole | 31 of 85 |
| Arm B: Albendazole | 26 of 84 |
| Arm C: Ivermectin and Albendazole | 34 of 86 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 11 of 85 | 10 of 84 | 18 of 86 |
| Headache | General disorders | 4 of 85 | 12 of 84 | 12 of 86 |
| Itching | Skin and subcutaneous tissue disorders | 9 of 85 | 11 of 84 | 5 of 86 |
| Symptoms related to immune system activation | Immune system disorders | 4 of 85 | 10 of 84 | 8 of 86 |
| Diarrhea | Gastrointestinal disorders | 6 of 85 | 4 of 84 | 7 of 86 |
| Nausea | General disorders | 4 of 85 | 2 of 84 | 5 of 86 |
| Allergic reaction | General disorders | 2 of 85 | 0 of 84 | 2 of 86 |
The registry reports serious adverse events for the safety groups in all three arms. The serious-event counts are 0 in the moxidectin-and-albendazole arm, 0 in the albendazole-alone arm, and 0 in the ivermectin-and-albendazole arm. The corresponding numbers at risk are 85, 84, and 86. These are the reported safety denominators, which differ from the arm sizes listed for the primary cure-rate analysis.
The record also reports other adverse events affecting 31 participants in the moxidectin-and-albendazole safety group, 26 in the albendazole-alone group, and 34 in the ivermectin-and-albendazole group. These figures should not be mistaken for serious adverse events: the registry separates the serious-event counts from the other adverse-event counts. Deaths are reported as 0 in each of the three groups.
In general, a zero count means no event of the specified category was recorded in that group during the reported safety assessment; it does not demonstrate that the risk is absent. Event counts also depend on the period of observation, definitions, collection procedures, and completeness of reporting. The registry record does not provide serious-event terms, because no top serious-event terms are listed, or details about event severity and relatedness for the other adverse events. The counts are descriptive and do not establish comparative safety.
12. What the Result Does, and Does Not, Mean
The registry result describes cure rates at the specified follow-up among participants included in the available-case analysis. The estimate is 15.3% for moxidectin plus albendazole and 13.4% for albendazole alone. The confidence intervals indicate uncertainty around those arm-level estimates. The point estimate is numerically higher for the combination, but the posted results do not include a direct treatment contrast, its confidence interval, or a p-value. A comparative conclusion should not be drawn from the point estimates alone.
The result does not establish what happened to participants whose outcomes were unavailable, because missing-data counts and handling are not reported. It does not describe egg-count reduction, which is a separate listed outcome, and it does not answer the results for ascariasis or hookworm. It also does not provide the primary cure-rate estimate for the ivermectin-and-albendazole arm. The adverse-event counts are separate descriptive safety information and do not substitute for efficacy comparisons.
In general, trial estimates are most informative when read alongside the design, analysis population, outcome definition, and uncertainty. Randomization and masking are recorded, but relevant implementation details are absent. The available registry results offer a bounded account of the measured outcome in the analyzed groups; they do not resolve every question about bias, missing data, or the comparative effect.
The observed percentages should not be interpreted as an individual prediction or as a guarantee of outcome. They apply to the endpoint definition and follow-up described in the registry, in the study population and setting recorded. The registry record does not report longer-term outcomes, the trial's full statistical analysis plan, or a complete account of all analysis decisions. Accordingly, the strongest supported reading is descriptive: the two posted arm estimates are close in point-estimate terms, with substantial uncertainty, and formal comparative evidence is not reported.
13. Why This Trial Matters Statistically
This trial illustrates why a treatment comparison is more than a comparison of two percentages. The registry posts a cure-rate estimate and confidence interval for each of the two arms in the primary comparison. Those summaries convey the observed response and its uncertainty, but they are not themselves an estimate of the between-arm effect. A reader needs the comparative analysis, including its uncertainty and method, to assess the trial's primary contrast formally.
It also shows the importance of defining the analysis population. The primary result is available-case, while the registry's enrollment figure is 255 and the outcome-specific arm sizes are 72 and 67. Those figures refer to different aspects of the record and should not be treated as interchangeable. Information about missing outcomes and their handling is necessary to judge how well the available cases represent the randomized groups.
The trial includes more than one treatment arm and a broad set of outcomes, including infection-specific efficacy measures and adverse events. That makes transparent outcome selection and multiplicity handling important. The registry record does not report a testing hierarchy or adjustment strategy, and the primary comparative test is not posted. This limits what can be concluded from the registry results, even though the study design is randomized and masked.
For clinical researchers and biostatisticians, the central lesson is to separate descriptive results, inferential comparisons, and design claims. The posted arm estimates are useful, but they do not replace details of the analysis plan, missing-data assessment, and outcome-by-outcome reporting. Careful interpretation keeps those distinctions explicit.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report a primary comparative effect estimate, confidence interval for the contrast, or p-value. It therefore supports description of the posted arm-level cure rates, but not a complete assessment of the primary treatment comparison. The absence of an analysis entry does not establish that no analysis occurred; the comparative analysis is simply not reported in the registry record.
The outcome analysis is identified as available case, but missing-outcome counts, reasons for missingness, and missing-data methods are not given. The record does not specify whether the primary analysis followed an intention-to-treat approach or whether other analysis populations were used. The outcome-specific sample sizes are different from the safety denominators, and the record does not explain the relationship between these populations.
The registry describes quadruple masking in its design fields and double-blinding in the study summary, without explaining the difference. Details on random-sequence generation, allocation concealment, masking roles, protocol deviations, and the statistical model are not reported in the registry record. The record also does not state the sample-size justification or how multiplicity across the listed outcomes was addressed.
The posted primary estimates do not include the ivermectin-and-albendazole arm. Secondary outcomes are listed, but their detailed results are not included among the primary values. Safety information gives counts, but not detailed event terms, severity, relatedness, or observation-period context. These reporting gaps constrain assessment of comparative efficacy, safety, and potential bias. They do not establish that the omitted methods or results were absent from the full trial documentation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of MOX/ALB Co-administration — NCT04726969.
- Registry record last updated 2024-01-24; status last verified 2024-01.
- Results first posted 2023-02-02.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT04726969 is a completed phase 3 randomized parallel-group trial of treatment regimens for Trichuris trichiura infection, with quadruple masking recorded in the design fields. The trial compared moxidectin plus albendazole, ivermectin plus albendazole, and albendazole alone. Its registry enrollment is 255, and its recorded study dates are 2021-06-15 to 2021-09-09 for start and primary completion.
The primary endpoint was cure rate 14-21 days after treatment, defined by conversion from egg-positive before treatment to egg-negative after treatment. For the available-case primary comparison, the registry reports 15.3% (95% confidence interval 7.9% to 25.7%) for moxidectin plus albendazole and 13.4% (95% confidence interval 6.3% to 24.0%) for albendazole alone. A direct comparative estimate and test are not reported in the registry record.
Serious adverse-event counts are 0 in each treatment group. The record lists 13 outcome measures and 8 posted secondary outcomes, but the full multiplicity strategy, missing-data handling, and primary analysis plan are not reported.