Trial · NCT00471445
Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
NCT00471445, Phase 3, Completed, Gary Morrow; results first posted 2015-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients. Trials, record NCT00471445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00471445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
- NCT number
- NCT00471445
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 462 participants, actual
- Lead sponsor
- Gary Morrow
- Conditions
- Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- ketamine/amitriptyline NP-H cream, placebo
- First posted
- 2007-05-10
- Last updated
- 2015-11-09
- Results first posted
- 2015-06-10
- Limitations and caveats
Since ketamine and amitriptyline are both analgesics, it is possible that the effects of the ketamine plus amitriptyline-containing creams may have been diluted when all three neuropathy symptoms were assessed together.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo | Week 6 - Baseline | Cancer survivors who completed chemotherapy at least 1 month prior and had Chemotherapy Induced Peripheral Neuropathy (CIPN) (greater than or equal to 4 out of 10) were enrolled. CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average "pain, numbness, or tingling in their hands and feet over the past 24 hours" on an 11-point numeric rating scale at baseline and 6 weeks post intervention. CIPN ranges from 0 (no pain) to 10 (worst possible pain). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo | Week 6 - Baseline | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo | Ketamine/Amitriptyline NP-H Cream | Baseline | 6.55 | 95% Confidence Interval 6.35 to 6.76 | units on a scale |
| Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo | Placebo Cream | Baseline | 6.47 | 95% Confidence Interval 6.28 to 6.66 | units on a scale |
| Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo | Ketamine/Amitriptyline NP-H Cream | Week 6 | 4.93 | 95% Confidence Interval 4.59 to 5.27 | units on a scale |
| Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo | Placebo Cream | Week 6 | 5.19 | 95% Confidence Interval 4.89 to 5.49 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 229 | |
| Overall Study | STARTED | Placebo Cream | 233 | |
| Overall Study | COMPLETED | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 227 | |
| Overall Study | COMPLETED | Placebo Cream | 231 | |
| Overall Study | NOT COMPLETED | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 2 | |
| Overall Study | NOT COMPLETED | Placebo Cream | 2 |
Source ClinicalTrials.gov
Adverse events170
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anorexia | Metabolism and nutrition disorders | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 3 | 227 | |
| other | Anorexia | Metabolism and nutrition disorders | Placebo Cream | 1 | 231 | |
| other | Chills | Metabolism and nutrition disorders | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 0 | 227 | |
| other | Chills | Metabolism and nutrition disorders | Placebo Cream | 2 | 231 | |
| other | Dehydration | Metabolism and nutrition disorders | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 2 | 227 | |
| other | Dehydration | Metabolism and nutrition disorders | Placebo Cream | 1 | 231 | |
| other | Dizziness | Ear and labyrinth disorders | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 2 | 227 | |
| other | Dizziness | Ear and labyrinth disorders | Placebo Cream | 3 | 231 | |
| other | Drymouth | Metabolism and nutrition disorders | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 1 | 227 | |
| other | Drymouth | Metabolism and nutrition disorders | Placebo Cream | 0 | 231 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | ||
| Total, all-cause mortality | Placebo Cream | ||
| Total, other adverse events | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 147 | 227 |
| Total, other adverse events | Placebo Cream | 158 | 231 |
| Total, serious adverse events | Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr | 4 | 227 |
| Total, serious adverse events | Placebo Cream | 4 | 231 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24531792 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA037420 | University of Rochester Cancer Center CCOP Research Base | MORROW, GARY R | UNIVERSITY OF ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2014 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr vs Placebo Cream: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00471445
GET https://conductscience.org/api/trials/v1/NCT00471445/events?page=2