Comparison · NCT01533428-sae
Capsaicin 8% vs Placebo: 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. Capsaicin 8% vs Placebo: serious adverse events. Trial comparisons, record NCT01533428-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01533428-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 | 0.0108 | 0.00295 | 0.0384 | wilson | |
| Risk in group 2 | 0.0383 | 0.0187 | 0.0768 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0275 | -0.0669 | 0.00635 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.281 | 0.0592 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 0.273 | 0.056 | 1.33 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Capsaicin 8% than on Placebo | 36.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | 2 | 186 | EG000 |
| Group 2 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 | 7 | 183 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were reported from the first application of study drug to Week 12 weeks
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
- NCT number
- NCT01533428
- Phases
- PHASE3
- Conditions
- Diabetic Peripheral Neuropathy, Pain
- Interventions
- Capsaicin 8%, Placebo
- Lead sponsor
- Astellas Pharma Inc
- Results first posted
- 2015-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01533428?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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