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NCT00516503 · OUTCOME

Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks

Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer · Source last updated 2017-08-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale * week
Interval / dispersion
Standard Deviation
Time frame
Up to 4 weeks

What was measured

The Peripheral Neuropathy Questionnaire was used to analyze this endpoint. Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic). The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.

Groups in this outcome

Baclofen-amitriptyline Hydrochloride-ketamine

Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.

Placebo

Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Baclofen-amitriptyline Hydrochloride-ketamine101
Placebo102

Reported measurements

Source class 1
Values in units on a scale * week · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baclofen-amitriptyline Hydrochloride-ketamine172.682.09Not reportedNot reportedNot reported
Placebo175.785.38Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.09
        value
        172.6
      2. group Id
        OG001
        spread
        85.38
        value
        175.7
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      102
    units
    Participants
description
The Peripheral Neuropathy Questionnaire was used to analyze this endpoint. Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic). The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.
dispersion Type
Standard Deviation
groups
  1. description
    Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
    id
    OG000
    title
    Baclofen-amitriptyline Hydrochloride-ketamine
  2. description
    Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
    id
    OG001
    title
    Placebo
param Type
MEAN
reporting Status
POSTED
time Frame
Up to 4 weeks
title
Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks
type
SECONDARY
unit Of Measure
units on a scale * week

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice