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 Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers (NCT01090141), a randomized phase 4 study. The primary outcome is Serum Clearance of Micafungin.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01090141 |
| Phase | Phase 4 |
| Condition | Obesity, Nutrition Disorders, Overweight |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 36 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Healthy volunteers described as having different weight groups. The registry record lists obesity, nutrition disorders, and overweight among the conditions. It does not report the weight-group definitions or the number of volunteers in each group.
Intervention
Micafungin at 100 mg or 300 mg, in separate randomized arms. The record does not explain how dose assignment related to weight group, or provide further details about how the drug was administered.
Comparator
The two micafungin dose arms are the listed comparison. There is no placebo or untreated arm in the arm descriptions. The record does not report whether the main intended comparison was between doses, weight groups, or both.
Primary question
How does serum clearance of micafungin vary among volunteers in different weight groups during the stated 0-24 Hrs timeframe? Although dose arms are listed, the registry record does not specify a single planned contrast or provide an estimate answering this question.
This is a pharmacokinetic question: it concerns the handling of a drug in the body, rather than a clinical outcome or a comparison of symptoms. The study summary says the purpose was to assess micafungin drug concentration among healthy volunteers with different weight groups. The listed primary outcome is serum clearance, which is related to drug concentration over time but is not itself a concentration value. The record does not report the endpoint’s unit, a detailed measurement definition, or the individual measurement schedule beyond the 0-24 Hrs timeframe.
The registered design was randomized and parallel, with separate 100 mg and 300 mg arms. It is therefore important not to treat the two dose descriptions as evidence that participants were assigned by weight group, or that dose and weight effects were independently assessed. The registry does not describe a factorial design or a particular model for separating those effects. Its stated primary question is best read as a broad pharmacokinetic aim, not as a fully specified statistical contrast. The absence of posted results means the record cannot establish how clearance differed across weight groups or doses.
3. Trial Design
The registry describes a completed phase 4 study with randomized allocation, no masking, and a parallel model. It lists enrollment of 36. The two arm descriptions are subjects receiving 100 mg of micafungin and subjects receiving 300 mg of micafungin. The record does not state how enrollment was distributed across these arms or across weight groups, nor does it describe the randomization procedure.
The study title and brief summary identify overweight, obese, and extremely obese volunteers as the population of interest; the summary describes them as healthy volunteers. The conditions listed in the registry are obesity, nutrition disorders, and overweight. Definitions for the weight categories, eligibility criteria, recruitment methods, and participant characteristics are not reported in the registry record. The arm descriptions do not provide additional details about the volunteers or explain whether each arm included all weight groups.
The record lists the University of Texas Southwestern Medical Center as sponsor. The study start is recorded as 2009-11 and primary completion as 2010-05, and the status is completed. These registration details establish the intended overall design and timing, but not how the study was conducted in practice. The masking entry is none; the record does not explain who knew treatment assignment or whether outcome assessment was blinded.
There is one listed primary outcome measure, serum clearance of micafungin, with a timeframe of 0-24 Hrs. The registry does not include a reported unit or detailed outcome description. It records no posted analyses and does not give outcome estimates. Thus, the design can be described, but the comparative results cannot be reconstructed from the registry record. Details such as a protocol, analysis population, sample-size justification, and prespecified statistical model are not reported in the registry record.
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.
Before assignment: The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available
Overall Study
| Stage | Subjects Recieving 100 mg of Micafungin | Subjects Recieving 300 mg of Micafungin |
|---|---|---|
| STARTED | 0 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available
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.
Population: The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available
| Characteristic | Unit | Subjects Recieving 100 mg of Micafungin | Subjects Recieving 300 mg of Micafungin | Total |
|---|---|---|---|---|
| Participants analysed | 0 | 0 | 0 | |
| Sex: Female, Male: Female | — | — | — | |
| Sex: Female, Male: Male | — | — | — | |
| Region of Enrollment: United States | participants | — | — | — |
6. Primary Endpoint
The registry lists the primary outcome as Serum Clearance of Micafungin, measured over 0-24 Hrs.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is serum clearance of micafungin over the stated 0-24 Hrs timeframe. Clearance is a pharmacokinetic measure: in general, it describes the volume of fluid from which a drug is removed per unit of time. It is used to characterize drug disposition, alongside concentration measurements, and can help describe whether drug exposure differs across groups. This is a general explanation of the measure, not a claim about the result in this study.
The registry record does not specify the unit, calculation method, sampling schedule, or exact definition used for serum clearance. Although the study summary refers to assessing drug concentration, the primary endpoint is registered as clearance, not a particular concentration or concentration change. The timeframe alone does not establish when individual samples were taken or how a value was derived.
The record does not report clearance values, variability, confidence intervals, or a statistical comparison. It also does not identify a single dose or weight-group contrast for this endpoint. Consequently, the measure’s intended role can be explained, but the observed relationship between micafungin clearance, dose, and weight group cannot be evaluated from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized, parallel study of micafungin in healthy volunteers from different weight groups. Its primary outcome is serum clearance over 0-24 Hrs, and its arms are listed as 100 mg and 300 mg. These details define the study’s broad subject and design, but they do not provide an estimate of clearance or a comparison between groups.
No outcome values or analysis results are reported in the registry record. The record lists one outcome measure and no analyses. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Therefore, there is no posted single estimate, uncertainty interval, or test result to interpret as evidence of a difference or similarity. The record does not support a conclusion about how clearance varied by weight group or dose.
The endpoint’s timeframe should not be confused with a reported result. The stated 0-24 Hrs period describes the outcome timeframe; it does not say that clearance was constant over that period, or provide a set of measurements at particular times. The registry also gives no unit or method for calculating the endpoint. Without those details and the numerical results, the magnitude and precision of any group comparison are unavailable.
The registry’s adverse-event entries list zero participants at risk and zero affected for serious and other events in each dose arm, with zero deaths. These entries are administrative counts in the posted record; without information about ascertainment, reporting completeness, or the analyzed safety population, they do not establish that no adverse events occurred. They should not be treated as a complete safety analysis.
The stated sample-size framework is an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such planning illustrations can show the sample size that would be associated with specified assumptions; they are not observed trial outcomes or observed power. The registry does not report the trial’s own sample-size justification. In the absence of posted outcome estimates and analysis details, the planning framework does not resolve the primary pharmacokinetic question.
9. Statistical Methods Explained
The study is registered as randomized, unmasked, and parallel. In general, randomization uses an assignment process intended to reduce systematic differences between treatment groups at baseline. A parallel design assigns participants to a group whose intervention is compared with another group, rather than having each participant receive every intervention in sequence. These are general descriptions of design terms; the registry does not report its randomization method, allocation concealment, or operational details. The absence of masking means the record does not describe masking, but it does not identify which people knew assignments or how that could have affected measurements.
What does the endpoint represent?
In general, clearance describes drug removal in relation to concentration and time. It is a pharmacokinetic quantity used to characterize drug disposition. A concentration measurement and a clearance estimate are related but are not interchangeable endpoints. The registered endpoint is serum clearance of micafungin, and the timeframe is 0-24 Hrs. The unit, calculation, and underlying sampling schedule are not reported in the registry record. As a result, the exact operational definition cannot be evaluated. A timeframe does not by itself indicate the number or timing of samples or whether the outcome is a single summary or a series of measurements.
How should a group comparison be interpreted?
In general, an effect estimate describes the direction and magnitude of a contrast, while a confidence interval describes the range of values compatible with the data and the method used. A narrow interval indicates greater precision than a wide interval under that method; neither an estimate nor its interval alone establishes clinical importance. A significance test addresses compatibility with a specified null model, not whether an effect is meaningful or whether the study question has been answered completely. These general principles cannot be applied to a numerical estimate in this case because outcome estimates, confidence intervals, and test results are not reported in the registry record.
The registry names two dose arms but does not state a single planned contrast. A comparison of doses would answer a different question from a comparison among weight groups, and evaluating both could require a model that accounts for both factors. This is a general distinction, not a claim about the analysis performed. The record does not report such a model, adjusted estimates, covariates, or an analysis population. The note that the primary outcome has several categories or time points and was not reduced to one comparison further limits interpretation: there is no single posted contrast to treat as the definitive primary result.
Why can variability matter?
In general, measurements of drug disposition can vary between participants. A mean or other summary describes a group, but its precision depends on the amount and pattern of variability as well as the amount of usable information. If variation is greater than a simple model assumes, a standard analysis can understate uncertainty; methods that account for over-dispersion can produce more appropriate uncertainty estimates. This is a general statistical point, not a description of this study. The registry does not report the distribution of clearance, a dispersion measure, or a model from which to assess whether over-dispersion was present.
Likewise, an adjusted analysis can account for measured covariates, while an unadjusted analysis compares groups without such adjustment. Either approach requires transparent specification and data. The registry record does not identify whether the intended or performed analysis was adjusted, whether repeated measurements were modeled, or how any assumptions were checked. No recalculated estimate is available from the posted summary statistics, and no sponsor analysis is reported for comparison.
What do planning illustrations tell the reader?
The stated planning framework uses the observed effect as a basis for illustrations, with the effect to detect expressed as a fraction of that observed effect. It specifies a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. For non-time-to-event outcomes, the stated output is participants per arm; time-to-event calculations are described in terms of total events. These are planning conventions, not results from the enrolled study, and do not show observed power. They are conditional on assumptions and should not be confused with a sample-size justification used when the study was designed. The registry does not report that justification or the specific statistical plan. Since no numerical outcome estimate is reported in the record, the planning assumptions cannot supply a missing interpretation of the clearance outcome.
More generally, a sample-size calculation depends on the target effect, variability, design, and analysis assumptions. Changing the target effect changes the planning requirement, and a planning result is not evidence that the planned or completed study detected an effect. Equal allocation is an assumption in the stated illustration, not a documented description of the actual allocation. The registry reports enrollment of 36, but not the numbers randomized or analyzed in each arm. The design and planning information therefore need to be kept separate from the unreported outcome evidence.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure, but also notes that the outcome has several categories or time points and was not reduced to one comparison. It does not report which comparisons, time points, or categories were considered primary for statistical testing. Without that specification, multiplicity cannot be assessed from the registry record. In general, when several comparisons are made, the chance of at least one apparently unusual result can increase; statistical plans may address this through prespecified contrasts or adjustments. No such plan is reported.
The record lists no analyses and provides no outcome results. It does not report whether analyses were prespecified, whether interim analyses occurred, or which statistical test or model was used. Those details are not reported in the registry record and should not be inferred from the randomized parallel design.
Missing-data handling and analysis populations are also not reported in the registry record. There is no account of withdrawals, missing measurements, exclusions, protocol deviations, or the number of participants included in any analysis. The enrollment entry alone does not establish how many participants contributed endpoint data. The primary outcome description includes a note that the original investigator had left the institution and that efforts to locate the original data had not established where those data were. This makes the lack of posted outcome analysis especially important, but it does not identify how much data may have been collected or retained.
In general, an analysis population should be defined so readers understand which randomized participants contribute to each estimate, while missing-data methods describe how unavailable measurements are handled. Neither can be evaluated. Consequently, any interpretation of selection, attrition, or multiplicity remains unresolved rather than settled by the registry entry.
11. What the Result Does, and Does Not, Mean
The record establishes that a completed randomized, parallel study was registered to examine micafungin pharmacokinetics among healthy volunteers in different weight groups. It identifies 100 mg and 300 mg dose arms and serum clearance during 0-24 Hrs as the primary outcome. Those details describe the research question and design, but do not answer whether clearance differed by dose or weight group.
No numerical outcome results, estimates of uncertainty, or analyses are reported in the registry record. The absence of a reported comparison is not evidence that groups were equal, nor is it evidence that they differed. It also does not establish that the study failed to collect measurements. The record’s note about efforts to locate the original investigator and data explains a limitation in the record, not what the unposted measurements would have shown.
The zero entries in the adverse-event record are not a complete safety conclusion. They are listed counts without accompanying descriptions of collection, follow-up, or reporting completeness. They cannot establish that no events occurred or support a comparison of safety between the dose arms.
The planning framework must also be interpreted separately from trial findings. It is described as an illustration based on an observed effect, with stated statistical assumptions; planning illustrations are not observed power and are not evidence of a treatment effect. The registry does not provide a sample-size justification used for the trial. Overall, the posted information supports a description of the registered design and endpoint, but not an efficacy, safety, or pharmacokinetic conclusion.
In general, a result is most informative when the estimate, its precision, analysis population, and analytic method are all available. Here those elements are not reported in the registry record. Any stronger conclusion would require data and methodological information that the record does not contain.
12. Why This Trial Matters Statistically
This study is statistically notable as a case where a registered pharmacokinetic question is identifiable but its analysis is not available in the registry record. The record names serum clearance, a timeframe, and dose arms, yet gives no endpoint estimates or analyses. That contrast highlights why registration details and posted results serve different purposes: the design can orient readers, while estimates and uncertainty are needed to assess what the data show.
The topic also illustrates the importance of distinguishing drug concentration from clearance. They are related concepts, but the registered primary outcome is clearance, whereas the brief summary describes measuring drug concentration. A precise endpoint definition, unit, and analysis method help readers understand what was measured and how conclusions were drawn. Those details are not reported in the registry record.
The study’s two dose arms and interest in different weight groups raise a design and analysis distinction. A dose comparison, a weight-group comparison, and an assessment of whether the dose relationship varies by weight group are different statistical questions. The registry does not identify the planned primary contrast or model, and the outcome is not reduced to a single comparison. Clear prespecification would help readers distinguish primary tests from additional comparisons and assess multiplicity.
Finally, the record’s note about difficulty locating the original data underscores the value of preserving outcome data and analysis documentation. Without those materials, readers cannot assess precision, missingness, model assumptions, or reproducibility. The statistical importance lies less in a result than in the limits on what can be concluded from the available record.
13. 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 most consequential limitation is the lack of posted outcome estimates and analyses. The registry lists serum clearance but no result values, uncertainty measures, or statistical comparisons. Its note says the original investigator had left the institution and that attempts to locate the original investigator and data had not established where the data were. This limits the ability to assess the primary pharmacokinetic question, but it does not reveal whether measurements were collected or what they would show.
The endpoint is not fully defined in the record. Its unit, calculation method, sample collection schedule, and detailed description are absent. The 0-24 Hrs timeframe supplies a broad window but not a measurement protocol. The brief summary refers to drug concentration while the primary outcome is clearance, making a more detailed definition particularly important for interpreting the intended measure.
Important design details are not reported in the registry record: weight-group thresholds, group sizes, allocation procedures, participant characteristics, the relationship between dose assignment and weight group, and masking procedures beyond the entry of none. The record also does not state the analysis population, missing-data approach, model, covariate adjustment, or multiplicity plan. The two dose arms therefore cannot be taken as proof that every dose-by-weight comparison was planned or analyzed.
The adverse-event entries show zeros, but the record does not explain ascertainment or completeness. These entries do not substitute for a detailed safety analysis. The registry further notes that the primary outcome includes several categories or time points and was not reduced to one comparison, so no single primary contrast can be interpreted. Taken together, these gaps prevent assessment of precision, robustness, and the extent to which the posted record reflects the full study.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers — NCT01090141.
- Registry record last updated 2020-11-27; status last verified 2020-11.
- Results first posted 2020-11-27.
- 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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17. Record Summary
NCT01090141 is a completed phase 4 randomized, unmasked, parallel study sponsored by the University of Texas Southwestern Medical Center. The registry lists enrollment of 36 and study dates of 2009-11 to 2010-05. Its title and summary describe micafungin concentration assessment among healthy volunteers in different weight groups.
The registered arms are 100 mg and 300 mg of micafungin. The primary outcome is serum clearance, with a 0-24 Hrs timeframe. The registry does not report a unit, outcome values, or analyses, and it does not specify a single comparison among doses and weight groups. It notes that the outcome has several categories or time points and was not reduced to one comparison.
The registry’s primary outcome description also records that the original investigator had left the institution and that attempts to locate the original data had not established where the data were. The record therefore describes the study’s design and intended endpoint but does not provide results with which to evaluate the primary question.