Comparison · NCT00471445-sae
Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr vs Placebo Cream: serious adverse events
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. Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr vs Placebo Cream: serious adverse events. Trial comparisons, record NCT00471445-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00471445-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 | 0.0176 | 0.00687 | 0.0444 | wilson | |
| Risk in group 2 | 0.0173 | 0.00675 | 0.0437 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000305 | -0.0282 | 0.0291 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.258 | 4.02 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.251 | 4.12 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr than on Placebo Cream | 3,280 | 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 | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically | 4 | 227 | EG000 |
| Group 2 | Placebo Cream | Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically | 4 | 231 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
- NCT number
- NCT00471445
- Phases
- PHASE3
- Conditions
- Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- ketamine/amitriptyline NP-H cream, placebo
- Lead sponsor
- Gary Morrow
- Results first posted
- 2015-06-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00471445?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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