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NCT00516503 · OUTCOME

Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4

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

Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint. Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale. 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

Worst Pain
Values in units on a scale * week · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baclofen-amitriptyline Hydrochloride-ketamine58.125.48Not reportedNot reportedNot reported
Placebo58.727.39Not reportedNot reportedNot reported
Least Pain
Values in units on a scale * week · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baclofen-amitriptyline Hydrochloride-ketamine78.020.28Not reportedNot reportedNot reported
Placebo77.322.01Not reportedNot reportedNot reported
Average Pain
Values in units on a scale * week · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baclofen-amitriptyline Hydrochloride-ketamine66.421.99Not reportedNot reportedNot reported
Placebo65.424.55Not reportedNot reportedNot reported
BPI Total Interference
Values in units on a scale * week · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baclofen-amitriptyline Hydrochloride-ketamine76.520.16Not reportedNot reportedNot reported
Placebo77.321.16Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.48
        value
        58.1
      2. group Id
        OG001
        spread
        27.39
        value
        58.7
    title
    Worst Pain
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.28
        value
        78.0
      2. group Id
        OG001
        spread
        22.01
        value
        77.3
    title
    Least Pain
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.99
        value
        66.4
      2. group Id
        OG001
        spread
        24.55
        value
        65.4
    title
    Average Pain
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.16
        value
        76.5
      2. group Id
        OG001
        spread
        21.16
        value
        77.3
    title
    BPI Total Interference
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      102
    units
    Participants
description
Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint. Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale. 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
Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4
type
SECONDARY
unit Of Measure
units on a scale * week

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

Preserved source evidence · Not medical advice