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 Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial (NCT00863551), a na phase 4 study. The primary outcome is Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00863551 |
| Phase | Phase 4 |
| Condition | Elderly, Pharmacokinetics, Overactive Bladder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns elderly subjects with overactive bladder symptoms. The registry record describes an intent-to-treat population as all patients who started the study. Enrollment was 12. Other eligibility details, including how elderly status or overactive bladder symptoms were defined, are not reported in the registry record.
Intervention
The intervention was trospium chloride extended release, 60 mg. The study evaluates drug levels at plasma steady state on Day 10, including a cerebrospinal-fluid measurement and peak and trough plasma measurements. The record identifies the drug but does not report the numerical concentrations.
Comparator
No concurrent comparator is described. The study is listed as a single-group study, with allocation recorded as NA and masking recorded as NONE. Baseline and Day 10 neurocognitive testing were to be compared within subjects, but that is not a separate untreated or active-control group.
Primary question
The primary outcome asks for the mean trospium concentration in cerebrospinal fluid at Day 10, Hour 5, measured in picograms per milliliter. This is a pharmacokinetic question about drug presence in cerebrospinal fluid at a stated time, rather than a treatment-effect comparison. The primary result itself is not reported in the registry record.
3. Trial Design
The registry record describes the Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial, a Phase 4, single-group study sponsored by Allergan. The listed intervention is trospium chloride extended release, 60 mg. Enrollment was 12. The record gives a study start of 2009-04 and primary completion of 2009-08, and lists the study status as completed.
Allocation is recorded as NA, and masking as NONE. These features mean the record does not describe a randomized, masked comparison. Instead, the design centers on measurements in participants receiving the study drug. It does not establish a like-for-like contrast between treatment groups, so a difference relative to a control condition cannot be estimated from the design described.
The brief summary says that trospium levels in cerebrospinal fluid and peak and trough plasma levels would be measured at plasma steady state on Day 10. It also describes baseline and Day 10 post-dose neurocognitive testing, with a reliable change index used to assess whether any subject showed a clinically and statistically significant change in memory. The registry record does not report the detailed schedule for all measurements or the numerical results of these assessments.
The listed primary outcome is mean cerebrospinal-fluid trospium level at Day 10, Hour 5, with standard deviation as the dispersion measure. The record also lists neurocognitive outcomes based on total and delayed recall scores from the Hopkins Verbal Learning Test-Revised and total and delayed recall scores from the Brief Visuospatial Memory Test-Revised. Those outcome descriptions refer to the percentage of subjects with no clinically significant effect. Numerical results for these outcomes 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.
Overall Study
| Stage | Trospium Chloride Extended Release, 60 mg |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat, which included all patients who started the study.
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 | Trospium Chloride Extended Release, 60 mg |
|---|---|---|
| Participants analysed | 12 | |
| Age, Continuous | years | 68 (65 to 74) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5, measured over Day 10, Hour 5.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Picograms per milliliter (pg/mL) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is cerebrospinal-fluid trospium concentration at Day 10, Hour 5. It is expressed in picograms per milliliter, and the registry record defines the summary as a mean with standard deviation. The endpoint description says cerebrospinal fluid was collected from each patient. The stated analysis population is intent-to-treat, defined in the record as all patients who started the study.
This measure addresses whether trospium is present in cerebrospinal fluid at the specified post-dose time. The study summary frames the measurement as an evaluation of penetration through the blood-brain barrier at plasma steady state. As a pharmacokinetic measurement, concentration describes drug level in a sampled fluid; it is not itself a neurocognitive outcome or a comparison of cognitive performance between treatment groups.
General statistical context: a mean describes the central value of a continuous measurement across the analyzed observations, while a standard deviation describes how spread out those observations are around the mean. Neither statistic, alone, shows the precision of the estimated mean as directly as a confidence interval would. The numerical mean, standard deviation, and any confidence interval for this endpoint are not reported in the registry record, so the magnitude and precision of the observed concentration cannot be assessed from the listed information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The design and endpoint define the scope of the evidence. This is a single-group study of trospium chloride extended release, 60 mg, in elderly subjects with overactive bladder symptoms. Its primary outcome is a cerebrospinal-fluid concentration at a specified time on Day 10. The registry record therefore describes a pharmacokinetic measurement, not a randomized comparison of treatment with placebo or another therapy.
The record does not report the primary endpoint’s mean or standard deviation. It also does not report a confidence interval, individual concentration values, or a statistical test for the endpoint. As a result, the posted record does not allow the reader to judge the level or precision of the measured cerebrospinal-fluid concentration. The endpoint definition tells the reader what was intended to be measured; it does not supply the measurement result.
The brief summary describes additional planned measurements: peak and trough plasma levels, and baseline and Day 10 neurocognitive testing. It says a reliable change index would be used to assess whether any subject showed evidence of a clinically and statistically significant change in memory. The neurocognitive outcomes listed include measures from the Hopkins Verbal Learning Test-Revised and the Brief Visuospatial Memory Test-Revised. Their numerical findings, and details of the reliable change index calculation, are not reported in the registry record.
Because there is no concurrent comparator, changes from baseline would be within-subject observations rather than a treatment-versus-control contrast. General statistical context: a before-and-after change can describe how measurements differ over time in the observed participants, but it cannot by itself distinguish a drug-related change from other explanations such as time, repeated testing, or natural variation. The record’s stated intention to assess reliable change is relevant to interpreting individual cognitive changes, but the specific method and results are unavailable.
The record lists enrollment as 12, and defines the primary population as patients who started the study. It does not report the number with an available primary endpoint measurement or explain whether any measurements were missing. The distinction matters because enrollment alone does not establish how many observations contributed to the reported mean. No numerical outcome estimates are available to support conclusions about the observed variation or the precision of the study’s measurements.
The registry record lists five outcome measures and zero analyses. The endpoint descriptions and study summary provide context about what was assessed, but they do not substitute for outcome estimates. Consequently, interpretation should remain limited to the design, planned measurements, and adverse-event counts recorded. No conclusion about the size of a pharmacokinetic or neurocognitive effect can be drawn from the numerical results, because those results are not reported in the registry record.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
The primary outcome is a continuous measurement: trospium concentration in cerebrospinal fluid, expressed in picograms per milliliter. The registry record specifies a mean and standard deviation. General statistical context: the mean summarizes the central level of a set of measurements, and the standard deviation describes their spread around that mean. A small spread would indicate that measurements are closer to the mean; a larger spread would indicate more variability. The record does not report either statistic for the primary outcome, so the observed concentration and its variability cannot be evaluated.
A standard deviation is not the same as uncertainty in the estimated mean. General statistical context: a confidence interval describes a range of values compatible with the data and the method used to estimate the quantity. Its width conveys precision, with a narrower interval generally indicating greater precision. The registry record does not report a confidence interval for the primary outcome. Without an estimate and its uncertainty, the outcome definition alone cannot establish how precisely the concentration was estimated.
What does a single-group design allow?
The model is listed as single group; allocation is NA and masking is NONE. No control group is described. General statistical context: a single-group study can describe measurements among participants receiving an intervention, including a measurement at a particular time or a change over time. It does not provide a randomized between-group estimate of the intervention’s effect against a control condition. Comparing baseline with follow-up can be informative descriptively, but changes may also reflect time, measurement variability, repeated testing, or other factors.
For this study, the primary endpoint is a concentration at Day 10, Hour 5, while the summary also describes baseline and Day 10 neurocognitive testing. Those are different kinds of measurements and address different questions. The concentration endpoint describes drug level in cerebrospinal fluid. The cognitive outcomes describe test performance or the stated classification of clinically significant effects. The registry record does not report numerical results for either set of outcomes.
How should the reliable change index be understood?
The brief summary says baseline and Day 10 post-dose neurocognitive testing would be compared using a reliable change index. General statistical context: a reliable change index is a way to assess whether an observed change in an individual’s test score is larger than expected from measurement error under the method’s assumptions. The meaning of a particular index depends on how it is calculated, including the test and the reliability assumptions used. The record does not report those calculation details, thresholds, or individual results. It therefore does not permit reconstruction or independent evaluation of the stated assessment.
The listed secondary outcomes focus on the percentage of study subjects with no clinically significant effect for selected scores on the Hopkins Verbal Learning Test-Revised and Brief Visuospatial Memory Test-Revised at Day 10 post-dose. A percentage of this kind depends on how the record defines a clinically significant effect and which participants have usable measurements. Those details and the numerical percentages are not reported in the registry record. The outcome wording should not be confused with proof that an effect was absent; it describes an outcome category that was intended to be summarized.
What does the analysis population mean?
The primary population is described as intent-to-treat and defined as all patients who started the study. This is the record’s stated population definition. General statistical context: the analysis population determines which participants are included in an estimate, and the handling of missing measurements can affect that estimate. Although enrollment was 12, the record does not report how many primary outcome measurements were available, whether all starters had a cerebrospinal-fluid sample, or how missing observations were handled. Enrollment and the number analyzed should not be treated as interchangeable.
What can be inferred from the planning information?
The record includes a general description of sample-size illustrations based on an observed effect and specified planning assumptions, including a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that these illustrations are not the trial’s own design. This study is listed as single group and has no like-for-like control comparison, so the planning assumptions do not describe the design recorded for this trial. No numerical planning estimates are reported in the registry record. General statistical context: a planning sample size is an illustration of how a future study might be designed under stated assumptions; it is not an observed result and is not observed power.
The record reports zero analyses. This means the registry record does not present statistical analysis results alongside the outcome descriptions. In particular, it does not report hypothesis tests, adjusted estimates, or a statistical model for the primary endpoint. No analysis plan or detailed statistical methods are reported in the registry record. In the absence of those details and of numerical outcomes, interpretation is limited to the endpoint definitions, population description, design, and counts that are recorded.
10. Multiplicity, Missing Data and Analysis Populations
The record lists five outcome measures: the primary cerebrospinal-fluid concentration outcome and neurocognitive outcomes based on total and delayed recall scores from two named tests. It reports zero analyses. The registry record does not report a multiplicity adjustment, a hierarchy for interpreting outcomes, or an explanation of how results across multiple outcomes would be handled. General statistical context: when many outcomes or tests are examined, the chance of at least one apparently unusual result can increase. Prespecified priorities and appropriate methods can help readers distinguish primary evidence from exploratory findings, but those methods are not described in the registry record.
Missing-data handling is not reported in the registry record. The primary population is defined as all patients who started the study, but the record does not state how many had an available cerebrospinal-fluid measurement or how missing values, if any, were treated. The numerical outcome estimates are also not reported. Therefore, neither the amount of missing outcome information nor its possible influence on estimates can be assessed.
The brief summary describes baseline and Day 10 neurocognitive testing, but the registry record does not report completion counts, scoring details, or results for those assessments. It also does not report whether any analyses were conducted on a population different from the stated primary population. These omissions limit interpretation of both the completeness of the outcome data and the relationship between the planned assessments and the reported 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 |
|---|---|---|---|
| Trospium Chloride Extended Release, 60 mg | 0 | 12 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Trospium Chloride Extended Release, 60 mg | 10 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Trospium Chloride Extended Release, 60 mg |
|---|---|---|
| Headache | Nervous system disorders | 7 of 12 |
| Nausea | Gastrointestinal disorders | 3 of 12 |
| Vomiting | Gastrointestinal disorders | 3 of 12 |
| Constipation | Gastrointestinal disorders | 2 of 12 |
| Dry Mouth | Gastrointestinal disorders | 2 of 12 |
| Flatulence | Gastrointestinal disorders | 2 of 12 |
| Low back pain | Musculoskeletal and connective tissue disorders | 2 of 12 |
| Folliculitis | Skin and subcutaneous tissue disorders | 1 of 12 |
| Change in taste | General disorders | 1 of 12 |
| Increased appetite | Metabolism and nutrition disorders | 1 of 12 |
For the listed trospium chloride extended-release group, the registry record reports 0 participants affected by serious adverse events among 12 at risk. It reports 10 participants affected by other adverse events among 12 at risk. These are counts recorded for the group, not comparisons against a control group. No serious adverse-event terms are listed. The death count is not reported in the registry record.
General statistical context: adverse-event counts describe events or affected participants as defined and recorded by the registry, and they do not by themselves establish whether an event was caused by the intervention. The record does not provide event descriptions for the other adverse events, severity details, timing, duration, or individual-level information. It also does not report a comparator group that could help contextualize these counts.
The safety figures should therefore be read as registry counts within the treated group, not as a comparative risk estimate. They do not provide enough detail to characterize the nature of the other adverse events or to determine their relationship to treatment. The record’s adverse-event fields identify the affected and at-risk counts, while further details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record identifies a focused pharmacokinetic question: the mean trospium level in cerebrospinal fluid at Day 10, Hour 5, among elderly subjects with overactive bladder symptoms receiving trospium chloride extended release, 60 mg. The study summary connects this measurement to evaluation of penetration through the blood-brain barrier at plasma steady state. The endpoint’s unit and summary measure are specified, but its numerical result is not reported in the registry record.
The record also describes planned plasma measurements and neurocognitive testing at baseline and Day 10. It lists outcomes based on total and delayed recall measures from the Hopkins Verbal Learning Test-Revised and the Brief Visuospatial Memory Test-Revised. These descriptions clarify what the study intended to assess, but the numerical findings, analysis details, and missing-data handling are not reported. The record therefore does not establish the observed size or precision of any concentration or cognitive change.
The single-group design is important to interpretation. It can characterize measurements recorded among participants in the study, but it does not offer a randomized comparator for estimating a treatment-versus-control difference. The within-subject neurocognitive assessment described in the summary is not equivalent to a controlled comparison. General statistical context: measurements taken before and after an intervention can change for reasons other than the intervention, so a change alone does not identify its cause.
The adverse-event counts describe participants affected within the treated group. The record reports no participants affected by serious adverse events and reports participants affected by other adverse events, but does not provide enough detail to characterize those other events or attribute them to treatment. Taken together, the record supports a description of the study’s design, objectives, and recorded safety counts. It does not support a conclusion about the magnitude of the primary pharmacokinetic result or the neurocognitive outcomes, because those outcome results are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for the way its question and design align around a measured drug concentration rather than a between-group treatment contrast. The primary endpoint is a continuous cerebrospinal-fluid concentration at a specified time. Its mean and standard deviation would describe the level and variability of the measurements, while uncertainty estimates would help indicate precision. The registry record specifies the summary form but does not report the numerical estimate or its uncertainty.
The single-group design also makes the distinction between description and causal comparison especially important. With no concurrent comparator described, the primary concentration can only be interpreted as a measurement in the study population and setting. The planned baseline-to-Day 10 neurocognitive assessment can describe within-subject change, but it cannot alone separate intervention-related change from other influences. This is a general design limitation, not a finding about the direction of any outcome.
The study summary’s reference to a reliable change index highlights a second statistical issue: individual change is not automatically meaningful change. General statistical context: a method for evaluating reliable change needs clearly stated measurement assumptions and decision criteria. The record does not report the calculation details or the results of that assessment, so readers cannot evaluate how the stated criterion was applied.
Finally, the record lists multiple outcomes but no analyses. Without numerical estimates, details of missingness, or a reported approach to interpreting multiple outcomes, the outcome descriptions alone cannot establish what was observed. The trial is therefore useful as an example of why endpoint definitions, analysis populations, and reported results all matter: the design and measurement question are identifiable, but the evidence needed to quantify the findings is not reported in the registry record.
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 principal limitation for interpreting this trial record is that numerical results for the primary endpoint are not reported in the registry record. Although the endpoint is defined as mean cerebrospinal-fluid trospium level at Day 10, Hour 5, with standard deviation, neither statistic is reported. The record also does not report an interval estimate or individual measurements. The magnitude and precision of the primary outcome therefore cannot be assessed.
The design is single group, with allocation recorded as NA and masking recorded as NONE. No concurrent comparator is described. This limits the study’s ability to support a controlled estimate of differences attributable to treatment. The neurocognitive assessment described in the summary uses baseline and Day 10 testing, but results and detailed analysis methods are not reported in the registry record.
The record does not report the number of participants with available primary outcome data, how missing measurements were handled, or whether all patients who started the study contributed to each outcome. It defines the primary population as all patients who started the study, while enrollment is 12; the relationship between that population and the measurements analyzed is not reported. Detailed eligibility criteria and the methods used to define clinically significant cognitive change are also not reported.
The listed outcomes include multiple neurocognitive measures, but the registry record reports zero analyses and does not report a multiplicity strategy. It also does not report numerical findings for the secondary outcomes or the planned plasma measurements. Safety information is limited to affected and at-risk counts; event descriptions and the death count are not reported. These record-level omissions constrain interpretation without establishing what the unreported results would have shown.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial — NCT00863551.
- Registry record last updated 2016-02-26; status last verified 2016-01.
- Results first posted 2011-12-19.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed Phase 4, single-group study sponsored by Allergan, with enrollment of 12 and a listed intervention of trospium chloride extended release, 60 mg. The study start is recorded as 2009-04 and primary completion as 2009-08. Allocation is NA and masking is NONE.
The primary endpoint is mean cerebrospinal-fluid trospium concentration at Day 10, Hour 5, in picograms per milliliter, with standard deviation. The summary also describes plasma measurements and baseline and Day 10 neurocognitive testing. Numerical outcome results and analyses are not reported in the registry record. For adverse events, the record reports 0 affected by serious adverse events among 12 at risk and 10 affected by other adverse events among 12 at risk; the death count is not reported.