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NCT00471445 · ClinicalTrials.gov registry record · Phase 3
Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
A Phase 3 study, sponsored by Gary Morrow.
- Completed
- Registry status
- Phase 3
- Development phase
- 462
- Enrollment target
NCT00471445: Completed Phase 3 study, sponsored by Gary Morrow.
NCT00471445 is a Phase 3 study that has completed, run by Gary Morrow. The registered enrollment target is 462 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00471445, a Phase 3 study, has completed, sponsored by Gary Morrow.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 462 participants
- Enrollment target
Study Summary
RATIONALE: Topical cream containing amitriptyline and ketamine may help relieve pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether topical amitriptyline and ketamine cream is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying the side effects and how well topical amitriptyline and ketamine cream work compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Primary Outcome
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).
Interventions
- OTHER placebo
- DRUG ketamine/amitriptyline NP-H cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT00471445 record still lists
NCT00471445 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00471445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00471445 about?
NCT00471445 is a clinical study titled "Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients". RATIONALE: Topical cream containing amitriptyline and ketamine may help relieve pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether topical amitriptyline and ketamine cream is more effective than a placebo in treating peripheral neuropathy caused by che...
What is the current status of trial NCT00471445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2007-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00471445?
The interventions under investigation include: placebo (OTHER), ketamine/amitriptyline NP-H cream (DRUG).
Who is sponsoring clinical trial NCT00471445?
This trial is sponsored by Gary Morrow, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00471445's enrollment target sits among peer trials
462 821st of 2000 higher than 1,179 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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