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 Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer (NCT00726830), a randomized na study. The primary outcome is Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00726830 |
| Phase | NA |
| Condition | Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Oncology-hematology outpatients with cancer and pain management problems who were currently receiving morphine or oxycodone. The registry lists several cancer and blood-disorder conditions, as well as pain and other conditions.
Intervention
Switch from the current opioid to oral methadone, taken 2-3 times daily for 4 weeks.
Comparator
Switch to another long-acting strong opioid: participants receiving oxycodone switched to sustained-release morphine, while those receiving morphine switched to sustained-release oxycodone. The alternative was taken 2-3 times daily for 4 weeks.
Primary question
How many participants had at least a 3-point reduction in M.D. Anderson Symptom Inventory average pain intensity by the 28-day assessment?
The registry describes a randomized comparison of two opioid-rotation strategies. One strategy switched participants from their current oxycodone or morphine to methadone. The other switched participants between sustained-release morphine and oxycodone, according to the opioid they were already taking.
The primary endpoint focused on change in pain intensity, assessed with the M.D. Anderson Symptom Inventory (MDASI). The registry defines primary success as a reduction of at least 3 points from baseline in the average pain intensity score. The MDASI pain scale runs from 0, meaning no pain, to 10, meaning worst pain.
The clinical question cannot be answered from the posted outcome data. The study was terminated, enrollment was 1, and the primary outcome record says no analysis was accomplished because there was not sufficient participant data to meet the study endpoints. No comparative estimate of pain reduction between the strategies is reported in the registry record.
3. Trial Design
The registry identifies this as a randomized trial with no masking. It lists methadone, morphine, and oxycodone as the drug interventions. The trial compared opioid rotation to oral methadone with rotation between sustained-release morphine and oxycodone. Participants assigned to the methadone strategy were switched from their current oxycodone or morphine. Participants in the other strategy were switched to the alternative long-acting opioid. Both arm descriptions specify dosing 2-3 times daily for 4 weeks.
The registry lists the study model as single group while also identifying the allocation as randomized and describing two treatment arms. These are different registry descriptors; the record does not explain the single-group classification or reconcile it with the randomized arm descriptions. No further detail about sequence generation, allocation concealment, or implementation of randomization is reported in the registry record. Masking is listed as none.
The study status is terminated. Enrollment is listed as 1. The registry gives a start date of 2009-03 and a primary completion date of 2010-09. The sponsor is M.D. Anderson Cancer Center. The phase is listed as NA.
The primary outcome was the number of participants with at least a 3-point reduction in MDASI pain score, with a timeframe of 28 days. The registry describes MDASI questionnaires on days 8, 15, and 22 after enrollment and comparison of baseline with the score from four weeks later. A secondary outcome concerned participants with a 30% reduction in the total summary score for individual items on the Composite Drug Toxicity Score. The record lists two outcome measures, but no analysis was accomplished because participant data were insufficient to meet the endpoints.
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 I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid |
|---|---|---|
| STARTED | 1 | 0 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: No Analysis accomplished as there is not sufficient participant data to meet the study end points.
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 I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 0 | 1 | |
| Age, Categorical: <=18 years | Participants | 0 | — | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | — | 1 |
| Age, Categorical: >=65 years | Participants | 0 | — | 0 |
| Sex: Female, Male: Female | Participants | 1 | — | 1 |
| Sex: Female, Male: Male | Participants | 0 | — | 0 |
| Region of Enrollment: United States | participants | 1 | — | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI), measured over 28 days.
| 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 the number of participants with at least a 3-point reduction in pain score on the M.D. Anderson Symptom Inventory (MDASI). The registry describes average pain intensity on a scale from 0, no pain, to 10, worst pain. Primary success is defined as a 3-point reduction from baseline, assessed at four weeks; the outcome timeframe is listed as 28 days.
The MDASI provides a structured way to record pain intensity rather than relying on an unstructured description. Comparing baseline with a later assessment focuses the endpoint on change within participants. Defining success by a threshold turns that change into a count of participants meeting the stated response criterion. Such a count can be useful for describing how many participants reached a prespecified level of improvement, provided enough outcome data are available.
The record says questionnaires were completed on days 8, 15, and 22 after enrollment, and describes comparison of baseline with the score from four weeks later. It does not report the actual pain scores, the number meeting the threshold, or a treatment-group comparison. The registry states that no analysis was accomplished because participant data were insufficient to meet the study endpoints. Thus, the endpoint is defined, but its observed value and comparative interpretation are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized study of two opioid-rotation strategies, but it does not contain an interpretable primary outcome comparison. Enrollment is listed as 1, the study status is terminated, and the primary outcome description explicitly says that no analysis was accomplished because there was not sufficient participant data to meet the study endpoints. No number of participants achieving the primary pain-reduction threshold is reported, and no estimate comparing the strategies is available.
Consequently, there is no reported estimate of the size or direction of a treatment difference, and no confidence interval or test result for the primary endpoint. A confidence interval, in general, describes the range of values compatible with an estimate under the statistical method used. Without an analyzed estimate, there is no interval from this record that can describe the precision of a possible difference. The absence of an estimate should not be interpreted as evidence that the strategies had the same outcome.
Although the study is described as randomized, random allocation alone cannot establish a comparative result when outcome data are insufficient for analysis. The registry record does not report how many participants were assigned to each strategy, nor does it report the primary outcome by arm. The enrollment total is not a substitute for arm-specific outcome information. The registry model is listed as single group even though the allocation and arm descriptions indicate a randomized comparison; the record does not explain this difference.
The primary endpoint was a threshold response: at least a 3-point reduction in MDASI pain score at 28 days. The registry also describes questionnaires on days 8, 15, and 22, but does not report results at those time points. The secondary outcome concerns a 30% reduction in the total summary score for individual Composite Drug Toxicity Score items; its result is also not reported. The listed outcome definitions therefore describe intended measurements, not observed findings.
No inferential conclusion about comparative pain outcomes can be drawn from the posted results. This is a limitation of the available record, not a finding that either strategy was ineffective, equivalent, or superior. The results are too incomplete to characterize the outcome response or its precision. The same caution applies to safety: the adverse-event counts are sparse, and the record does not report deaths. These figures do not establish a comparative safety profile.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization assigns participants to treatment strategies using a chance-based process. When implemented as intended, it can help balance participant characteristics across groups and support a fair comparison. It does not guarantee that groups will be balanced in every small study, and it cannot create an analyzable treatment comparison when outcome information is insufficient. The registry lists randomized allocation and no masking, but further details about how randomization was generated or carried out are not reported in the registry record.
What does the primary endpoint count?
The primary endpoint is a count of participants meeting a response threshold: at least a 3-point reduction in MDASI pain score. In general, a threshold endpoint classifies each participant according to whether the defined change was reached. The resulting count or proportion can be compared between groups when the relevant group sizes and outcome classifications are available. Those results are not reported in the registry record. The endpoint definition alone cannot establish how many participants responded.
How should repeated assessments be understood?
The MDASI description refers to questionnaires on days 8, 15, and 22 after enrollment, and a comparison between baseline and the score from four weeks later. Repeated assessments can describe how an outcome changes over time. They may also raise analysis questions, such as which assessment is primary and how results from multiple time points are handled. The registry does not report an analysis method for repeated measurements, and the primary outcome description says the comparison is between baseline and four weeks later. No results for the listed assessment days are reported.
What can an effect estimate and confidence interval show?
In general, an effect estimate describes the observed contrast between treatment groups, while a confidence interval communicates uncertainty around that estimate under a specified statistical method. The width of an interval is related to precision: a wider interval reflects less precise information than a narrower one. Neither an estimate nor an interval is reported for the primary comparison. Therefore, the precision of any treatment contrast cannot be assessed from this registry record. No p-value or other primary comparison result is reported either.
Why does the available sample matter?
Statistical comparisons depend on outcome information from participants in the groups being compared. Sparse information limits the ability to estimate group outcomes and their uncertainty. Here, enrollment is listed as 1, and the registry states that the available participant data were insufficient to meet the endpoints. The record does not report arm-specific enrollment or a completed primary analysis. These registry entries prevent a useful estimate of a comparative effect; they do not demonstrate that the strategies have identical effects.
General planning calculations can illustrate how participant numbers might relate to a target effect and statistical assumptions. The registry describes planning illustrations based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also distinguishes participants per arm for non-time-to-event outcomes from total events for time-to-event outcomes. Those descriptions are planning assumptions, not outcomes of this trial. No numeric planning results are reported in the registry record, and an observed effect for this trial is not available because the primary analysis was not accomplished. Planning illustrations should not be described as observed power.
What is not established about the statistical plan?
The registry record does not report the statistical analysis plan, a sample-size justification, interim analyses, or a completed inferential analysis. It also does not report a specific model for comparing treatment groups, any adjustment variables, or a method for handling repeated outcome measurements. These details should not be inferred from the randomized designation or from the endpoint definition. The posted information supports a description of the planned comparison and the reasons the primary analysis is absent, but not a reconstruction of the intended analysis beyond those stated details.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome based on MDASI pain reduction and a secondary outcome based on reduction in the Composite Drug Toxicity Score. It also describes MDASI questionnaires on days 8, 15, and 22 after enrollment, alongside comparison of baseline with the assessment four weeks later. Considering more than one outcome or time point can create multiplicity: in general, the more statistical comparisons made, the greater the chance of finding an apparently notable result by chance. Statistical plans can address this through prespecified priorities or adjustment methods. The registry record does not report whether any multiplicity strategy was planned.
No analysis was accomplished because participant data were insufficient to meet the study endpoints. Therefore, no tested comparison or multiplicity-adjusted result is reported. The record does not specify whether the secondary outcome or individual assessment times were intended for formal hypothesis testing.
The registry does not report a missing-data method, an analysis population definition, or a participant flow account detailing assignment, treatment received, and outcome availability. It does not state how participants with incomplete questionnaires would have been handled, or whether any imputation or sensitivity analysis was planned. Those details are not reported in the registry record and cannot be inferred from the endpoint description.
The stated enrollment of 1 and the absence of a primary analysis mean that there is no reported analysis population from which to assess exclusions or missing outcome patterns. The registry’s statement that data were insufficient explains why an analysis was not accomplished, but it does not give further detail about the extent or pattern of missingness.
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 I: Opioid Rotation to Oral Methadone | 0 | 1 | 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 |
|---|---|
| Arm I: Opioid Rotation to Oral Methadone | 0 of 1 |
| Arm II: Opioid Rotation to Another Long-acting Strong Opioid | 0 of 0 |
The serious adverse-event figures list the methadone arm with 1 participant at risk and 0 affected. The other long-acting opioid arm lists 0 participants at risk and 0 affected. The record lists 1 participant at risk and 0 affected for other adverse events in the methadone arm, and 0 at risk and 0 affected in the other arm. Death counts are null in both groups, so deaths are not reported in the registry record.
These figures are sparse and should be read alongside the listed risk denominators. A count of 0 affected among 0 participants at risk does not describe an observed event rate for that arm; there are no participants represented in that denominator. A count of 0 affected among 1 participant at risk is also too limited to characterize safety reliably. The registry does not provide a comparative safety analysis or further details about event ascertainment. These counts do not establish that serious or other adverse events could not occur, or that the treatment strategies differ in safety.
12. What the Result Does, and Does Not, Mean
The record documents a randomized study comparing a switch to oral methadone with switching between sustained-release morphine and oxycodone for oncology-hematology outpatients with pain management problems. It defines a primary pain-response endpoint and a secondary toxicity-score outcome. It also describes treatment schedules and the timing of symptom assessments. These details identify the intended clinical comparison and the outcomes the study was designed to assess.
What the record does not provide is a completed efficacy analysis. The study was terminated, enrollment was 1, and the primary outcome entry states that analysis was not accomplished because participant data were insufficient to meet the endpoints. No response count, group comparison, effect estimate, confidence interval, or significance test for the primary outcome is reported. The secondary outcome result is not reported either.
Accordingly, the record cannot show whether one rotation strategy led to a greater pain-score reduction, whether the strategies had similar outcomes, or how precisely any difference could be estimated. Lack of a reported result is not a result of no difference. It is also not evidence that either treatment did or did not help participants.
The adverse-event counts are limited and have small or absent denominators, and deaths are not reported. They do not provide a basis for comparing safety. Overall, the posted results describe an incomplete trial record rather than an estimate that can support a statistical conclusion about comparative benefit or harm.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the distinction between a well-defined clinical question and an answerable comparative analysis. The registry describes randomized allocation, two opioid-rotation strategies, a pain-response threshold, and a follow-up timeframe. Yet those design features cannot yield a treatment comparison without adequate participant outcome data. The record itself states that analysis was not accomplished because there was not sufficient participant data to meet the endpoints.
The study also demonstrates why outcome definitions should be separated from outcome results. A threshold of at least a 3-point reduction in MDASI pain score identifies what would count as primary success. It does not tell readers how many participants achieved it, whether the number differed across strategies, or how uncertain a comparison would be. Those questions require observed data and an analysis, neither of which is reported.
The registry’s combination of randomized allocation with a single-group model designation also illustrates the need to read design descriptors alongside the trial arms and outcome information. The record does not explain that classification, so the discrepancy should not be resolved by assumption.
Finally, the sparse safety denominators and null death counts show why event counts need context. A zero count is not independently informative about comparative risk when the number at risk is absent or very small. Taken together, these features make the record useful for understanding the intended study question and the limits of the posted evidence, but not for estimating comparative treatment effects.
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 most important limitation is the absence of an accomplished primary outcome analysis. The registry states that participant data were insufficient to meet the study endpoints, and enrollment is listed as 1. No primary response count or comparison between treatment strategies is reported. The resulting absence of an estimate also prevents assessment of statistical precision.
The record lists the study as terminated but does not report the reason for termination. It does not explain whether the enrollment shown represents all participants who entered the study, how participants were assigned, or how many received each strategy. Although allocation is listed as randomized, the model is listed as single group; the registry does not explain this difference.
The primary outcome description gives a threshold and assessment schedule, but no observed MDASI scores or results at the listed time points are reported. The secondary toxicity-score outcome is identified, but its result is not reported. The statistical analysis plan, sample-size justification, interim analyses, analysis populations, and methods for handling missing data are not reported in the registry record.
Safety information is also limited. The adverse-event counts have small or zero risk denominators, and death counts are null. The record does not provide an analysis comparing adverse events across strategies. These limitations mean that neither efficacy nor comparative safety can be characterized from the posted results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer — NCT00726830.
- Registry record last updated 2020-09-24; status last verified 2020-09.
- Results first posted 2012-12-06.
- 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
NCT00726830, titled “Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer,” was sponsored by M.D. Anderson Cancer Center. The registry lists randomized allocation, no masking, a single-group model designation, and a terminated status. Enrollment is listed as 1.
The study compared opioid rotation to oral methadone with switching between sustained-release morphine and oxycodone. The primary outcome was the number of participants with at least a 3-point reduction in MDASI pain score at 28 days. A secondary outcome concerned a 30% reduction in the total summary score for individual Composite Drug Toxicity Score items.
The registry states that the primary outcome was not analyzed because participant data were insufficient to meet the study endpoints. No efficacy comparison is reported. Safety counts are sparse, and deaths are not reported in the registry record.