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 Treating Chronic Insomnia in Breast Cancer Patients (NCT00337272), a randomized phase 4 study. The primary outcome is Sleep Efficiency.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00337272 |
| Phase | Phase 4 |
| Condition | Chronic Insomnia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Accelerated Community Oncology Research Network |
| Results posted | Yes |
2. Clinical Question
Population
Patients with breast cancer and chronic insomnia following chemotherapy were the intended population. The official title describes patients following completion of chemotherapy, while the brief summary refers to patients who had completed their first chemotherapy treatment. The registry record does not explain this difference in wording or give further eligibility details. Enrollment was 16.
Intervention
Participants assigned to ramelteon were scheduled to take 8 mgs 30 minutes before bedtime on days 1-28 of the treatment period. The stated primary question concerns sleep efficiency, measured during screening, treatment, and withdrawal periods.
Comparator
The comparator was placebo, scheduled 30 minutes before bedtime on days 1-28 of the treatment period. The registry record describes a randomized, parallel-group design. The allocation ratio and the method used to generate or conceal the assignment sequence are not reported in the registry record.
Primary question
The primary endpoint was percent sleep efficiency, calculated from reported total sleep time and time in bed. The clinical question is whether the recorded sleep-efficiency measurements differed between the ramelteon and placebo groups over the recorded periods. The registry record lists the endpoint and its measurement schedule, but does not report a numerical group comparison, effect estimate, uncertainty interval, or statistical test. It therefore does not establish the direction or precision of any difference from the posted primary-outcome information.
3. Trial Design
The registry record identifies this as a Phase IV, randomized, triple-masked, parallel-group study of ramelteon and placebo. Its title concerns treatment of chronic insomnia in patients with breast cancer following completion of chemotherapy. The brief summary describes the intended participants as having completed their first chemotherapy treatment for breast cancer. The record does not clarify the relationship between those descriptions.
The registered enrollment was 16, and the study status is terminated. The start is recorded as 2006-08 and primary completion as 2008-08. The reason for termination, the date of termination, and whether the study ended as planned are not reported in the registry record. The record does not describe the randomization sequence, allocation concealment, or the number of participants originally assigned to each arm at randomization.
The ramelteon arm was scheduled to receive 8 mgs 30 minutes before bedtime on days 1-28 of the treatment period. The placebo arm was scheduled to take placebo on the same bedtime schedule over days 1-28. Sleep efficiency was assessed every morning during the screening, treatment, and withdrawal periods. The number of participants with primary-outcome measurements varied by period: screening included 14 patients, treatment included 13, and withdrawal included 10. The arm counts also varied across those periods, as described in the primary outcome information.
The listed secondary outcomes cover quantitative sleep measures, qualitative sleep assessments, and daytime function. The registry record does not describe a protocol for handling deviations from the scheduled treatment, the length of the screening and withdrawal periods, or the methods used to maintain masking. Those details should not be inferred from the design labels alone.
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: After consent, subjects underwent a 2 week screening period to see if they met the criteria for insomnia and to assess compliance with daily Interactive Voice Recognition System (IVRS) calls.
Screening Period (Pre-randomization)
| Stage | 1 (Placebo) | 2 (Ramelteon) |
|---|---|---|
| STARTED | 22 | 0 |
| COMPLETED | 16 | 0 |
| NOT COMPLETED | 6 | 0 |
Reasons for not completing this period:
| Reason | 1 (Placebo) | 2 (Ramelteon) |
|---|---|---|
| Withdrawal by Subject | 2 | 0 |
| Non-compliance | 1 | 0 |
| Screen failure | 3 | 0 |
Treatment Period
| Stage | 1 (Placebo) | 2 (Ramelteon) |
|---|---|---|
| STARTED | 7 | 9 |
| Randomization | 7 | 9 |
| COMPLETED | 6 | 7 |
| NOT COMPLETED | 1 | 2 |
Reasons for not completing this period:
| Reason | 1 (Placebo) | 2 (Ramelteon) |
|---|---|---|
| Non-compliance | 1 | 1 |
| Withdrawal by Subject | 0 | 1 |
Withdrawal Period
| Stage | 1 (Placebo) | 2 (Ramelteon) |
|---|---|---|
| STARTED | 6 | 7 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | 1 (Placebo) | 2 (Ramelteon) |
|---|---|---|
| Non-compliance | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.
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 | 1 (Placebo) | 2 (Ramelteon) | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 9 | 16 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 9 | 16 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age Continuous | Years | 51.69 (SD 5.98) | 49.11 (SD 6.78) | 50.24 (SD 6.37) |
| Sex: Female, Male: Female | Participants | 7 | 9 | 16 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 2 | 2 |
| Race (NIH/OMB): White | Participants | 7 | 7 | 14 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 7 | 9 | 16 |
6. Primary Endpoint
The registry lists the primary outcome as Sleep Efficiency, measured over Every morning during the screening, treatment, and withdrawal periods.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percent sleep efficiency |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is percent sleep efficiency, a continuous measure intended to describe how much of the time spent in bed was spent sleeping. The registry defines total time in bed as the time a participant got out of bed minus the time the participant went to bed. Total sleep time is reported by the participant. Percent sleep efficiency is calculated as 100*(total sleep time divided by total time in bed).
This measure is useful for expressing sleep time relative to time in bed, rather than considering total sleep time alone. In general, a proportion-based sleep measure can help distinguish a change in time asleep from a change in time spent in bed. The endpoint is recorded every morning during the screening, treatment, and withdrawal periods, allowing measurements to be collected across more than one study period. The registry record does not specify how daily measurements were combined for the primary analysis, or whether a particular day, period average, or change from an earlier period defined the primary comparison.
The recorded unit is percent sleep efficiency, and the planned summary statistic is a mean with standard deviation. These descriptions identify the intended measurement and summary format; they do not supply an observed mean, group difference, or measure of uncertainty. No numerical primary-outcome results are reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record sets out a randomized comparison of ramelteon and placebo and identifies sleep efficiency as the primary endpoint. It also gives participant counts for that endpoint across screening, treatment, and withdrawal. However, it reports no primary-outcome values, group means, effect estimate, confidence interval, or statistical test. There is therefore no posted numerical basis for describing the size, direction, or precision of a difference between the assigned groups.
The measurement counts vary across periods. Screening has measurements for 14 patients, with 6 in the placebo group and 8 in the ramelteon group. Treatment has measurements for 13 patients, with 5 in the placebo group and 8 in the ramelteon group. Withdrawal has measurements for 10 patients, with 4 in the placebo group and 6 in the ramelteon group. These are the counts attached to the endpoint description, not estimates of treatment effect. The registry record does not explain why counts differ across periods or whether participants without a measurement stopped participation, missed a measurement, or had another reason for missing data.
The study enrollment is 16, but the endpoint counts are not identical to that enrollment in each period. The record does not report an analysis population or say how participants with incomplete measurements were handled. It also does not identify an analysis method for the repeated morning observations. Without those details and the outcome values, the available information cannot show whether a reported comparison, if one were made, accounted for within-participant correlation or missing measurements.
The status is terminated, and the record lists zero analyses. This means the registry record does not contain a statistical analysis result for the primary endpoint. It does not explain the termination or establish why analysis results are absent. The record lists secondary outcomes, but no numerical results for those outcomes are reported in the registry record either. Consequently, the posted information describes the study question and measurement plan more fully than it describes the results.
Any interpretation should remain limited to the registry information: a small enrolled study, repeated sleep-efficiency measurement over specified periods, and no posted primary comparison. A lack of reported results is not evidence of no difference, nor does it establish a difference. Precision cannot be judged without an estimate and an uncertainty interval. The design and endpoint alone do not answer the clinical question.
9. Statistical Methods Explained
What does the endpoint measure?
The primary outcome is a continuous measure, percent sleep efficiency. It is derived from total sleep time divided by total time in bed, multiplied by 100. The total time in bed calculation uses the reported time of getting out of bed minus the reported time of going to bed; total sleep time is reported by the participant. The registry specifies that the measure was to be collected every morning during screening, treatment, and withdrawal. It does not say whether the primary analysis used each daily value, a summary within each period, or another derived measure.
The record identifies mean and standard deviation as the summary parameter and dispersion measure. In general, a mean describes the center of a set of continuous measurements, while a standard deviation describes their spread around that mean. Neither summary alone describes the precision of a comparison between groups. A confidence interval is a general statistical tool for expressing uncertainty around an estimated quantity; no confidence interval for sleep efficiency is reported in the registry record.
How should the repeated measurements be understood?
Repeated morning measurements from the same participant are generally related, rather than independent observations. In general, an analysis of repeated measurements may account for that relationship and for any systematic changes over time. The registry record does not identify a repeated-measures model, a time-point-specific comparison, or another method for accounting for within-participant correlation. It also does not specify how screening, treatment, and withdrawal observations were used together in the primary analysis.
The counts reported for sleep efficiency differ by period and arm: screening includes 6 placebo and 8 ramelteon participants; treatment includes 5 placebo and 8 ramelteon participants; withdrawal includes 4 placebo and 6 ramelteon participants. These counts establish that the number of participants contributing measurements was not the same across all listed periods. They do not explain the missing observations or indicate whether the same participants contributed data in each period. The reasons and statistical handling of incomplete data are not reported in the registry record.
What would a group comparison require?
A comparison would ordinarily summarize the outcome in each arm and estimate a contrast between the groups, with a measure of uncertainty. For a continuous endpoint, the chosen contrast might be based on group means, but the registry record does not state the precise contrast or analysis model. No group means, differences, standard errors, confidence intervals, or p-values are posted for the primary endpoint. As a result, the statistical evidence and precision of a group comparison cannot be assessed from this record.
Randomization is intended, in general, to support a fair comparison by allocating participants to study groups without choosing assignment based on participant characteristics. The record labels the study randomized, but does not report sequence generation, concealment, allocation ratio, or the analysis population. The term triple-masked is recorded, but which groups or roles were masked and how masking was maintained are not reported in the registry record. These missing details limit assessment of how the planned design was implemented.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variability exceeds what a statistical model assumes. For a continuous outcome, unexpectedly large variability can make an analysis based on an overly restrictive variance assumption appear more precise than it is. The record gives standard deviation as the planned measure of spread, but no observed standard deviations or model assumptions are reported. There is therefore no basis to assess whether over-dispersion affected this trial's analysis.
What do the planning assumptions establish?
A planning illustration is described as using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Such calculations are planning illustrations, not observed trial findings or evidence that a study had a particular probability of detecting an effect. The registry record does not provide the numerical planning estimates or the observed primary effect needed to interpret them. It also does not report the trial's own sample-size justification, so the illustration should not be treated as the original design rationale.
In general, over-dispersion and repeated observations matter because the variance assumptions influence uncertainty estimates and tests. A suitable analysis needs to reflect the outcome scale, the relationship among observations from the same participant, and the pattern of available data. The registry record does not state how these considerations were handled. Since no analysis is reported, statistical methods beyond the measurement definition and planned mean with standard deviation cannot be attributed to the trial.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is sleep efficiency. The registry record also lists secondary outcomes addressing total sleep time, number of awakenings, global sleep impression, quality of sleep, fatigue, despair, and distress. It reports 8 outcome measures and zero analyses. No numerical findings for the primary or secondary outcomes are reported in the registry record.
When a study examines multiple outcomes or multiple time points, general statistical practice considers the possibility that some apparent findings may arise by chance. A multiplicity plan may specify which comparisons are confirmatory and whether adjustments or a hierarchy of tests will be used. The registry record does not report such a plan, nor does it report an interim-analysis plan. It is not possible to determine how multiplicity was addressed, or whether it was addressed, from the posted information.
The number of participants with sleep-efficiency measurements changes across screening, treatment, and withdrawal. The registry record does not describe reasons for missing measurements, imputation, or other missing-data procedures. It also does not state whether the primary analysis included all randomized participants, only participants with available measurements, or another analysis population. These omissions matter because different approaches to incomplete observations can produce different estimates and uncertainty.
The endpoint definition and counts indicate the intended measure and the available measurement counts by period, but do not establish how daily records were reduced or modeled. The statistical analysis plan, the handling of repeated observations, and the analysis populations 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 |
|---|---|---|---|
| 1 (Placebo) | 0 | 7 | 0.0% |
| 2 (Ramelteon) | 0 | 9 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 1 (Placebo) | 6 of 7 |
| 2 (Ramelteon) | 4 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 1 (Placebo) | 2 (Ramelteon) |
|---|---|---|---|
| Coughing | Respiratory, thoracic and mediastinal disorders | 2 of 7 | 1 of 9 |
| Sore throat | Respiratory, thoracic and mediastinal disorders | 1 of 7 | 2 of 9 |
| Abscess on right hip | Infections and infestations | 1 of 7 | 1 of 9 |
| Yeast infection | Infections and infestations | 1 of 7 | 1 of 9 |
| Headache | Nervous system disorders | 0 of 7 | 2 of 9 |
| Dry mouth | Gastrointestinal disorders | 0 of 7 | 1 of 9 |
| Hematochezia | Gastrointestinal disorders | 0 of 7 | 1 of 9 |
| Vomiting | Gastrointestinal disorders | 1 of 7 | 0 of 9 |
| Fatigue | General disorders | 0 of 7 | 1 of 9 |
| Leg edema | General disorders | 1 of 7 | 0 of 9 |
The registry safety summary lists 7 participants at risk in the placebo group and 9 in the ramelteon group. It lists 0 participants affected by serious adverse events in each group. The number of participants affected by other adverse events is listed as 6 for placebo and 4 for ramelteon. These are the registry counts; they do not by themselves describe event severity, timing, duration, or whether an event was considered related to study treatment.
The safety denominators differ from the sleep-efficiency counts reported for some periods. The registry record does not explain the relationship between those denominators and the participants contributing primary-outcome measurements. The death entries are not reported in the registry record. No serious adverse-event terms are listed.
In general, adverse-event counts describe events recorded in a study and require context about definitions, observation time, reporting completeness, and attribution. Those details are not reported in the registry record. The counts should not be read as a statistical comparison or as evidence about causation. The record reports no analysis of the safety figures.
12. What the Result Does, and Does Not, Mean
The registry record identifies the trial's objective, comparison, primary endpoint, measurement schedule, and counts of participants with sleep-efficiency measurements by period. It also records the safety counts and several secondary outcomes. These details clarify what the study was intended to examine, but they do not provide the primary results needed to judge the direction or magnitude of a group difference.
No numerical sleep-efficiency results or inferential statistics are reported in the registry record. Without group summaries and an effect estimate, there is no basis for saying whether the recorded values were higher or lower in either group. Without an uncertainty interval, the precision of any possible difference cannot be assessed. The record's terminated status does not explain why the study ended or what conclusions the investigators reached.
The absence of posted results does not establish that ramelteon and placebo were equivalent, and it does not establish that they differed. It also does not show that the endpoint was measured incorrectly or that the study failed to collect data. Those conclusions would require information not reported in the registry record.
The enrollment of 16 and the changing endpoint counts describe the scale and available measurements, but neither can substitute for an outcome analysis. The listed secondary measures broaden the topics of interest to sleep and daytime function, yet their results are also not reported. The record therefore supports a description of the registered study and its available registry entries, not a conclusion about treatment effects.
In general, a clinical result is interpreted using the estimated effect, its uncertainty, the analysis methods, and the study context. Here, the outcome estimates and analysis methods are not reported in the registry record. The appropriate statistical conclusion is that the posted record does not permit assessment of the primary comparison.
13. Why This Trial Matters Statistically
This trial is statistically notable because it planned repeated measurement of a continuous sleep outcome across screening, treatment, and withdrawal, yet the registry record gives no numerical analysis of that outcome. The period-specific participant counts make clear that the number of contributing observations varied. That pattern highlights why reporting both the analysis method and the handling of incomplete measurements is important for interpreting a repeated-measures study.
The randomized, parallel-group design creates a framework for comparing ramelteon with placebo, while the endpoint definition describes how sleep efficiency was to be derived. But a design and a measure are not themselves a result. To evaluate a comparison, readers need outcome summaries, an effect estimate, and a measure of its precision, together with enough information to understand which participants and measurements were analyzed.
The registry record also illustrates the distinction between a planned outcome list and analyzed results. It names sleep-related and daytime-function outcomes but records zero analyses. It does not report a multiplicity strategy, analysis populations, or missing-data methods. These omissions prevent a reader from assessing how the multiple outcomes and repeated observations were handled.
Finally, the terminated status and small enrollment are contextual features, not explanations for the absence of results. The termination reason and sample-size justification are not reported in the registry record. The statistical importance lies in the gap between a clearly identified measurement question and the lack of posted estimates needed to quantify an answer.
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.
Several trial-specific limitations of interpretation arise from the registry record. The primary outcome is described as a daily measure across screening, treatment, and withdrawal, but the method for combining or modeling those observations is not reported. The participant counts contributing to sleep-efficiency measurements vary by period, and the reasons for those changes are not reported. No missing-data approach or analysis population is identified.
The registry identifies randomization and triple masking, but does not describe sequence generation, allocation concealment, the allocation ratio, or which people were masked. It does not report the statistical analysis plan, the primary comparison definition, an interim-analysis plan, or a sample-size justification. The planned mean and standard deviation are specified, but no observed means, standard deviations, effect estimate, confidence interval, or p-value is reported.
Enrollment was 16 and the status is terminated. The reason for termination, whether enrollment ended as planned, and the consequences for the planned analyses are not reported in the registry record. The record does not provide the dates or duration of individual study periods beyond the treatment schedule of days 1-28. It also does not clarify the difference between the official title's wording about completion of chemotherapy and the brief summary's reference to completion of the first chemotherapy treatment.
The safety summary provides participant counts but not event descriptions, timing, attribution, or an analysis. These limitations restrict interpretation to the contents of the registry record and do not establish what may have been collected or analyzed outside it.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Treating Chronic Insomnia in Breast Cancer Patients — NCT00337272.
- Registry record last updated 2011-08-22; status last verified 2011-08.
- Results first posted 2009-07-21.
- 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
The registry record describes NCT00337272, a randomized, triple-masked, parallel-group Phase IV study of ramelteon versus placebo for chronic insomnia in patients with breast cancer following chemotherapy. Enrollment was 16. The recorded start is 2006-08, primary completion is 2008-08, and status is terminated.
The primary outcome is percent sleep efficiency, measured every morning during screening, treatment, and withdrawal. Ramelteon was scheduled at 8 mgs before bedtime on days 1-28, with placebo on the same schedule. The record lists 8 outcome measures and zero analyses. It does not report numerical primary-outcome results, inferential statistics, or the reason for termination. Safety counts list 0 serious adverse events in each group, while other adverse-event counts are 6 for placebo and 4 for ramelteon.