CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 208 enrolled
Drug / intervention
baclofen/amitriptyline/ketamine gel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00516503
NCT00516503Phase 3Completed

The Use of Topical Baclofen, Amitriptyline HCI, and Ketamine (BAK) in a PLO Gel vs. Placebo for the Treatment of Chemotherapy Induced Peripheral Neuropathy: A Phase III Randomized Double-Blind Placebo Controlled Study

Alliance for Clinical Trials in Oncology·interventional·Posted Aug 15, 2007·Updated Aug 24, 2017

In Brief

A Phase 3 clinical trial evaluating baclofen/amitriptyline/ketamine gel and placebo for Chronic Myeloproliferative Disorders and 9 related conditions. Completed, enrolled 208 participants across 165 sites.

Detailed Summary

RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy . PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Study Details

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2007
Enrollment StartFeb 1, 2008
Primary CompletionApr 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.9 years ago

Interventions

baclofen/amitriptyline/ketamine geldrug

Applied topically

placeboother

Applied topically