Comparison · NCT03295721-9d9d1a21
Treatment Group 1: HTX-011 vs Treatment Group 3: Bupivacaine HCI: Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Treatment Group 1: HTX-011 vs Treatment Group 3: Bupivacaine HCI: Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl. Trial comparisons, record NCT03295721-9d9d1a21. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03295721-9d9d1a21
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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 | 0.287 | 0.222 | 0.362 | wilson | |
| Risk in group 2 | 0.11 | 0.0696 | 0.169 | wilson | |
| Risk difference, group 1 minus group 2 | 0.177 | 0.0892 | 0.262 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.61 | 1.57 | 4.36 | log | |
| Odds ratio, group 1 over group 2 | 3.26 | 1.77 | 6.01 | log | |
| Number needed to treat, for one more participant with the outcome on Treatment Group 1: HTX-011 than on Treatment Group 3: Bupivacaine HCI | 5.65 | 3.82 | 11.2 | from the risk difference interval |
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 | Treatment Group 1: HTX-011 | HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation. | 45 | 157 | OG000 |
| Group 2 | Treatment Group 3: Bupivacaine HCI | Bupivacaine HCl without epinephrine, 50 mg by injection. | 17 | 155 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.
- Description
- Time frame
- 72 hours
- Population
- ITT Population
Source ClinicalTrials.gov
Trial
- Title
- Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
- NCT number
- NCT03295721
- Phases
- PHASE3
- Conditions
- Postoperative Pain
- Interventions
- HTX-011, Saline Placebo, Bupivacaine HCl, Luer-lock applicator, Vial access device
- Lead sponsor
- Heron Therapeutics
- Results first posted
- 2021-10-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03295721?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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