Comparison · NCT00930943-sae
Oxymorphone 40 mg With High-fat Meal vs Oxymorphone 40 mg Fasting: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Oxymorphone 40 mg With High-fat Meal vs Oxymorphone 40 mg Fasting: serious adverse events. Trial comparisons, record NCT00930943-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00930943-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.114 | wilson | |
| Risk in group 2 | 0 | 0 | 0.114 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.114 | 0.114 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Oxymorphone 40 mg With High-fat Meal | Participants were instructed not to eat or drink, except for water, after midnight on the night before testing, not to consume alcohol within 24 hours of testing and xanthine-containing beverages (coffee, tea, coca cola, energy drinks, etc.) on the morning of the testing. Subjects who were taking an oral opioid were instructed not to take their morning dose on the days of testing, and those who used the transdermal fentanyl patch were instructed not to change the patch the night before.~Each testing visit consisted of an assessment of adverse health and concomitant-medication changes and also a blood alcohol draw, followed by a high-fat breakfast. Under supervision, the subjects took the study medication, a single dose of 40 mg oxymorphone ER, with water. Cognitive performance was assessed 1 hour and 3 hours post-dose using three Cambridge Neuropsychological Test Automated Battery (CANTAB) tests. | 0 | 30 | EG000 |
| Group 2 | Oxymorphone 40 mg Fasting | Participants were instructed not to eat or drink, except for water, after midnight on the night before testing, not to consume alcohol within 24 hours of testing and xanthine-containing beverages (coffee, tea, coca cola, energy drinks, etc.) on the morning of the testing. Subjects who were taking an oral opioid were instructed not to take their morning dose on the days of testing, and those who used the transdermal fentanyl patch were instructed not to change the patch the night before.~Each testing visit consisted of an assessment of adverse health and concomitant-medication changes and also a blood alcohol draw. Under supervision, the subjects took the study medication, a single dose of 40 mg oxymorphone ER, with water. Cognitive performance was assessed 1 hour and 3 hours post-dose using three Cambridge Neuropsychological Test Automated Battery (CANTAB) tests. | 0 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
- NCT number
- NCT00930943
- Phases
- PHASE4
- Conditions
- Chronic Pain
- Interventions
- Oxymorphone ER
- Lead sponsor
- MedVadis Research Corporation
- Results first posted
- 2023-05-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00930943?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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