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 A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain (NCT00803283), a non-randomized phase 3 study. The primary outcome is Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00803283 |
| Phase | Phase 3 |
| Condition | Cancer Pain |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 2 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Taiwan Ltd |
| Results posted | Yes |
2. Clinical Question
Population
Participants with chronic malignant cancer pain. The registry record gives an enrollment of 2 and says the study was terminated because of poor enrollment.
Intervention
Hydromorphone HCl OROS, described as 8 mg every 24 hours during a titration phase lasting 3 to 14 days, followed by a 14-day maintenance phase at the investigator’s discretion.
Comparator
Morphine SR, described as 8 mg every 24 hours during a titration phase lasting 3 to 14 days, followed by a 14-day maintenance phase at the investigator’s discretion.
Primary question
What was the Brief Pain Inventory Item 3 score for worst pain at Day 14? The registry record says no efficacy data were summarized because the sample size was very low.
The clinical question was whether the two study medications could be compared for safety and efficacy in participants experiencing cancer pain. The primary endpoint focused on the participant’s rating of their worst pain, using Item 3 of the Brief Pain Inventory. The registry also lists outcomes covering other pain ratings, pain interference and relief, assessments by participants and investigators, breakthrough medication use, and the total daily dose of study medication.
The record identifies the study as Phase 3 and describes a parallel-group design. However, the allocation field classifies it as nonrandomized, while the official title calls it randomized. That disagreement matters for interpreting comparisons: the registry classification does not support treating the arms as a randomized, like-for-like comparison. The study was terminated, and the recorded reason was poor enrollment. Its posted results therefore do not answer the primary efficacy question.
3. Trial Design
The registry describes a Phase 3, parallel-group study of OROS hydromorphone HCl and morphine SR in participants with cancer pain. It records the study as open label, with no masking, and classifies allocation as nonrandomized. The official title, in contrast, describes the study as randomized. The registry record does not resolve this inconsistency, so the allocation classification should be kept in view when interpreting any arm-level comparison.
The intervention descriptions specify 8 mg every 24 hours for each medication during a titration phase lasting 3 to 14 days. They then describe a 14-day maintenance phase, with treatment continued at the investigator’s discretion. The study was terminated, and the registry gives poor enrollment as the reason. The recorded enrollment is 2. The primary endpoint was scheduled for assessment at Day 14.
The record says that only safety data were summarized and that no efficacy data were summarized because of the very low sample size. It lists 10 outcome measures and no analyses. Those entries do not establish that every planned measure was collected, nor do they supply estimates of treatment effects. The results therefore support a description of the limited posted safety counts, not an efficacy comparison.
The registry record does not report the rationale for the enrollment target, a detailed statistical analysis plan, or how treatment allocation was carried out. It also does not report whether treatment groups were balanced on participant characteristics. With nonrandomized allocation, differences between groups may reflect factors other than treatment; whether such factors were present in this study is 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 | Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | Morphine Sustain Release (SR) |
|---|---|---|
| STARTED | 1 | 1 |
| COMPLETED | 1 | 1 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
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 | Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | Morphine Sustain Release (SR) | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 1 | 2 | |
| Age, Customized: >=18 to <=40 years | Participants | 0 | 1 | 1 |
| Age, Customized: >=41 to <=60 years | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 0 | 1 | 1 |
| Sex: Female, Male: Male | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14, measured over Day 14.
| 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 was the Brief Pain Inventory (BPI) Questionnaire Item 3 score for worst pain at Day 14. The registry describes the BPI as a questionnaire that assesses pain severity and its impact on quality of life. For Item 3, the score ranges from 0, meaning no pain, to 10, meaning pain as bad as the participant can imagine. This is a participant-reported measure: it captures the participant’s assessment of their pain rather than an objective measurement of pain intensity.
A worst-pain rating can be useful in a clinical trial because it gives a defined symptom measure at a specified assessment time. As a general statistical point, a continuous score can describe a range of experiences rather than reducing responses to a simple yes-or-no outcome. The interpretation of a group comparison would still depend on how scores were collected, which participants contributed data, and how the comparison was analyzed. These details are not reported in the registry record.
The registry identifies Day 14 as the endpoint timeframe but reports that efficacy data were not summarized because the study was terminated after poor enrollment and the sample size was very low. There is therefore no posted Day 14 treatment-effect estimate or uncertainty interval to interpret. The endpoint definition tells the reader what the trial intended to assess; it does not establish what the participants’ scores were or whether the groups differed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The principal interpretive fact is that the trial does not report an efficacy result for its primary endpoint. The planned outcome was the BPI Item 3 worst-pain score at Day 14, on a scale from 0 to 10. The registry states that the study was terminated because of poor enrollment and that no efficacy data were summarized because the sample size was very low. Consequently, there is no posted estimate of the difference between the treatment groups, no confidence interval for that difference, and no efficacy test result to interpret.
The record reports an enrollment of 2. The safety entries show one participant at risk in each arm. For serious adverse events, zero affected participants are recorded in each arm. For other adverse events, one affected participant is recorded in the hydromorphone arm and zero in the morphine arm. These are very limited descriptive counts. They do not provide a precise comparison of safety, and they should not be interpreted as establishing that one medication has a higher or lower risk.
The allocation field says nonrandomized, although the official title describes a randomized study. The registry record does not explain the discrepancy. Since the record classifies allocation as nonrandomized, the arms should not be treated as a like-for-like randomized comparison. In general, random allocation helps reduce systematic differences between groups at the start of a study; without it, observed group differences can be entangled with differences in who received each treatment. The record does not report participant characteristics or allocation procedures that would help assess this issue.
The posted safety counts are also too sparse to support a broad safety profile. A count of zero affected participants in a small group is not proof that an event cannot occur, and an event in one participant does not establish that treatment caused it. The registry lists no serious adverse-event terms. Death counts are not reported in the registry record.
The study’s status and missing efficacy results constrain what can be concluded. The registry records the study as terminated, gives poor enrollment as the reason, and says only safety data were summarized. This means the primary clinical question remains unanswered by the posted results. The absence of an efficacy estimate is not evidence of no treatment effect, nor is it evidence that the treatments are equivalent. It reflects the lack of summarized efficacy data in this record.
Any planning illustrations based on an observed effect should be read cautiously in this context. No efficacy effect is reported in the registry record, and a planning calculation is not an observed trial finding or observed power. The analysis plan and the handling of uncertainty are not reported in the registry record. The available information therefore supports a narrow description of the design, the stated endpoint, termination, and sparse safety counts, rather than a treatment conclusion.
9. Statistical Methods Explained
What does the primary score represent?
The primary outcome is a participant-reported BPI Item 3 score for worst pain at Day 14. The scale runs from 0, no pain, to 10, pain as bad as the participant can imagine. A score is a measurement of a participant’s reported experience at the assessment time. It is not, by itself, a comparison between treatments. A treatment comparison would require the observed scores from each group and a defined method for estimating the difference and its uncertainty. Efficacy scores and such estimates are not reported in the registry record.
What would a confidence interval mean?
General: A confidence interval expresses uncertainty around an estimated quantity, such as a difference between group averages. A narrower interval indicates greater precision under the assumptions of the analysis; a wider interval indicates less precision. The interval is not a guarantee that the true value lies within its endpoints. In this study, no efficacy estimate or confidence interval is reported in the registry record, so the precision of a treatment comparison cannot be assessed from posted efficacy results.
Why does allocation matter?
The record classifies allocation as nonrandomized, while the official title uses the word randomized. The record does not explain this mismatch. General: Random allocation is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. In a nonrandomized study, treatment assignment may be related to participant characteristics or clinical decisions. That can make an observed group difference difficult to attribute to treatment alone. The record does not report enough detail about allocation or baseline characteristics to assess the extent of this concern.
The parallel-group label indicates that the study is described as having separate treatment groups, rather than each participant receiving both treatments in sequence. The open-label and no-masking entries indicate that masking is not recorded. General: Knowledge of treatment assignment can influence reporting, care, or assessment, particularly for subjective outcomes such as a pain questionnaire. The registry record does not describe procedures to address this possibility.
What can the safety counts tell us?
The posted safety information is descriptive: it gives the number at risk and the number affected for serious and other adverse events in each arm. In the hydromorphone arm, one participant was at risk for each category; zero were affected by a serious adverse event and one was affected by another adverse event. In the morphine arm, one participant was at risk for each category; zero were affected by a serious adverse event and zero were affected by another adverse event. These counts do not support a stable estimate of event frequency or a reliable between-group comparison.
General: Sparse event data are inherently imprecise. A zero count can occur even when an event is possible, while a single event can strongly influence a percentage in a small group. For that reason, safety counts from a very small study should be read as a record of what was reported, not as a comprehensive estimate of risk. The registry does not identify the non-serious event term, and no serious adverse-event terms are listed. Death counts are not reported in the registry record.
What do the planning assumptions mean?
The record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a description of the trial’s own design justification. The registry record does not report a sample-size justification or the statistical plan used for the trial.
General: A sample-size planning calculation asks how much information a future study might need to detect a specified effect under stated assumptions. It does not show that the current study had adequate power, and it is not a measure of observed power. When the underlying effect estimate comes from sparse data, planning illustrations can be especially uncertain. No efficacy effect is reported in this registry record, so there is no posted efficacy estimate to interpret as the basis for a clinical conclusion.
The record says that no efficacy data were summarized because the sample size was very low. It also lists no analyses. Thus, the reported planning framework should not be mistaken for an analysis of the primary endpoint or for evidence that an efficacy comparison was performed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the BPI Item 3 worst-pain score at Day 14 as the primary outcome. It also lists secondary outcomes addressing pain now, pain intensity, pain relief, pain interference, participant and investigator global assessments of effectiveness, breakthrough-pain medication use, and mean total daily dose of study medication. The registry record lists 10 outcome measures overall, but gives no analysis entries.
Multiplicity arises when several outcomes or statistical tests are considered. General: The more comparisons examined, the greater the chance that at least one result may appear noteworthy by chance. A prespecified analysis plan can describe how a study handles that issue, for example by prioritizing outcomes or adjusting inference. A multiplicity strategy is not reported in the registry record. Because no efficacy data were summarized, there are no posted efficacy tests or estimates with which to assess multiplicity in practice.
Missing-data procedures are not reported in the registry record. The record does not say whether endpoint observations were missing, how any missing scores would have been handled, or which analysis population was intended. It also does not report a detailed definition of the populations included in the efficacy or safety analyses. These omissions prevent assessment of whether the analyzed participants, if any, matched the groups intended by the study design.
The registry states that only safety data were summarized and that no efficacy data were summarized because of poor enrollment and very low sample size. This is different from an efficacy analysis finding no difference: no primary efficacy result is posted.
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 |
|---|---|---|---|
| Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | 0 | 1 | 0.0% |
| Morphine Sustain Release (SR) | 0 | 1 | 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 |
|---|---|
| Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | 1 of 1 |
| Morphine Sustain Release (SR) | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | Morphine Sustain Release (SR) |
|---|---|---|---|
| Oedema peripheral | General disorders | 1 of 1 | 0 of 1 |
| Anaemia | Blood and lymphatic system disorders | 1 of 1 | 0 of 1 |
| Chest discomfort | Gastrointestinal disorders | 1 of 1 | 0 of 1 |
| Abdominal distension | Gastrointestinal disorders | 1 of 1 | 0 of 1 |
The serious adverse-event entries report one participant at risk in each arm and zero affected participants in each arm. No serious adverse-event terms are listed. For other adverse events, the hydromorphone arm reports one participant at risk and one affected participant; the morphine arm reports one participant at risk and zero affected participants. These entries are small descriptive counts, not a precise comparison of safety between treatments.
General: With very sparse data, a single event can substantially affect an apparent group pattern, and a zero count does not establish that the event is impossible. The posted information does not identify the other adverse-event term or provide detail about event severity or relationship to treatment. The registry’s death entries are null, so deaths are not reported in the registry record. These limitations mean the counts should be read narrowly as the events recorded, without using them to infer a broader safety profile or causation.
12. What the Result Does, and Does Not, Mean
The record establishes that a Phase 3 study of OROS hydromorphone HCl and morphine SR was conducted for cancer pain, with a planned primary endpoint of worst pain on the BPI at Day 14. It also records that the study was terminated because of poor enrollment. The registry states that no efficacy data were summarized because the sample size was very low, and only safety data were summarized.
Accordingly, the record does not show whether either treatment produced a larger or smaller change in worst-pain scores. It does not establish that the treatments are equivalent, that they differ, or that either has an efficacy advantage. A missing efficacy result cannot be interpreted as a null effect. The endpoint definition describes what the study intended to measure, not the outcome observed.
The safety information documents zero serious adverse-event reports among the participants listed at risk in each arm, and one other adverse event in the hydromorphone arm versus zero in the morphine arm. Given the sparse counts, these observations do not establish comparative safety or explain whether an event was caused by treatment. The record does not list serious-event terms, and deaths are not reported in the registry record.
The nonrandomized allocation classification also limits comparison between arms, despite the official title’s use of randomized. The registry does not explain the inconsistency or report participant characteristics that might clarify comparability. The defensible interpretation is therefore narrow: the posted record describes a terminated study, its intended endpoint, and limited safety counts, but does not provide an interpretable efficacy comparison or a reliable basis for broad treatment conclusions.
13. Why This Trial Matters Statistically
This study illustrates how a clearly defined endpoint does not guarantee an informative result. The BPI Item 3 score gives a specified measure of worst pain and a stated assessment time, Day 14. Yet the record reports that poor enrollment led to termination and that efficacy data were not summarized because the sample size was very low. Without endpoint results, there is no estimate whose magnitude or precision can be evaluated.
It also illustrates why the design details used to interpret a comparison must be read carefully. The official title describes a randomized study, but the registry allocation field says nonrandomized. Since randomization is central to the interpretation of group comparisons, that inconsistency matters. The record does not provide enough information to resolve it or to assess whether the groups were comparable.
Finally, the safety entries show why counts and uncertainty must be distinguished. A very small set of recorded events can be described accurately, but it cannot support a stable comparison or comprehensive safety conclusions. General: Statistical interpretation depends not only on the direction of an observed result, but also on the amount and quality of information behind it. Here, the central efficacy outcome is unreported and the safety counts are sparse. The record is therefore more informative about limitations in the available evidence than about 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 study’s termination and the absence of summarized efficacy data are central limitations. The registry attributes termination to poor enrollment and says the sample size was very low. Although it identifies the primary endpoint and its timeframe, it provides no primary endpoint scores, treatment-effect estimate, confidence interval, or efficacy test result. The clinical efficacy question therefore cannot be answered from the posted results.
The allocation information is internally inconsistent: the official title describes a randomized study, while the allocation field classifies it as nonrandomized. The registry record does not explain this difference. It also does not report the allocation procedure or participant characteristics that could help assess group comparability. This makes any arm-level interpretation especially cautious.
The safety results involve very sparse counts. No serious adverse-event terms are listed, the other adverse-event term is not identified, and deaths are not reported in the registry record. These entries cannot characterize a full safety profile. The record also does not report missing-data methods, analysis populations, a detailed statistical analysis plan, multiplicity handling, or the rationale for the enrollment target. The treatment dosing description includes investigator discretion during maintenance, but the record does not describe how that discretion was applied.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain — NCT00803283.
- Registry record last updated 2013-08-12; status last verified 2013-08.
- Results first posted 2013-08-12.
- 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 a Phase 3, open-label, parallel-group study of OROS hydromorphone HCl versus morphine SR for cancer pain. It classifies allocation as nonrandomized, although the official title describes the study as randomized. The recorded enrollment is 2, and the study status is terminated; poor enrollment is given as the reason.
The primary endpoint was BPI Item 3 worst-pain score at Day 14, measured on a scale from 0 to 10. The registry says no efficacy data were summarized because the sample size was very low. Safety entries report zero serious adverse events in each arm and one other adverse event in the hydromorphone arm versus zero in the morphine arm. The record lists no analyses and does not report deaths, analysis populations, or a detailed statistical plan.