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NCT00538850 · OUTCOME

Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing

Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain · Source last updated 2014-03-05

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
Interval / dispersion
Standard Deviation
Time frame
5 through 60 minutes after dosing for each pain episode

What was measured

Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5\*PAR5), TOTPAR10=(5\*PAR5)+(5\*PAR10), TOTPAR15=(5\*PAR5)+(5\*PAR10)+(5\*PAR15), TOTPAR30=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30), TOTPAR45=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30)+(15\*PAR45), TOTPAR60=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30) +(15\*PAR45) +(15\*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.

Analysis population: Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.

Groups in this outcome

Fentanyl Sublingual Spray

Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.

Placebo

Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.

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

Analysis denominator · Participants

GroupSource count
Fentanyl Sublingual Spray92
Placebo92

Reported measurements

TOTPAR5
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray8.63.5Not reportedNot reportedNot reported
Placebo7.63.3Not reportedNot reportedNot reported
TOTPAR10
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray19.77.0Not reportedNot reportedNot reported
Placebo16.76.5Not reportedNot reportedNot reported
TOTPAR15
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray32.910.3Not reportedNot reportedNot reported
Placebo27.110.0Not reportedNot reportedNot reported
TOTPAR30
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray78.320.4Not reportedNot reportedNot reported
Placebo61.020.8Not reportedNot reportedNot reported
TOTPAR45
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray126.330.9Not reportedNot reportedNot reported
Placebo95.532.0Not reportedNot reportedNot reported
TOTPAR60
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray176.441.5Not reportedNot reportedNot reported
Placebo131.243.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.5
        value
        8.6
      2. group Id
        OG001
        spread
        3.3
        value
        7.6
    title
    TOTPAR5
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.0
        value
        19.7
      2. group Id
        OG001
        spread
        6.5
        value
        16.7
    title
    TOTPAR10
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.3
        value
        32.9
      2. group Id
        OG001
        spread
        10.0
        value
        27.1
    title
    TOTPAR15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.4
        value
        78.3
      2. group Id
        OG001
        spread
        20.8
        value
        61.0
    title
    TOTPAR30
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.9
        value
        126.3
      2. group Id
        OG001
        spread
        32.0
        value
        95.5
    title
    TOTPAR45
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.5
        value
        176.4
      2. group Id
        OG001
        spread
        43.6
        value
        131.2
    title
    TOTPAR60
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      92
    units
    Participants
description
Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5\*PAR5), TOTPAR10=(5\*PAR5)+(5\*PAR10), TOTPAR15=(5\*PAR5)+(5\*PAR10)+(5\*PAR15), TOTPAR30=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30), TOTPAR45=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30)+(15\*PAR45), TOTPAR60=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30) +(15\*PAR45) +(15\*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
    id
    OG000
    title
    Fentanyl Sublingual Spray
  2. description
    Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
reporting Status
POSTED
time Frame
5 through 60 minutes after dosing for each pain episode
title
Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
type
SECONDARY
unit Of Measure
Units on a scale

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

Preserved source evidence · Not medical advice