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NCT00538850 · OUTCOME

Summed Pain Intensity Differences (SPID) at 5, 10, 15, 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
Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode

What was measured

Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5\*PID5), SPID10=(5\*PID5)+(5\*PID10), SPID15=(5\*PID5)+(5\*PID10)+(5\*PID15), SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30), SPID45=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30)+(15\*PID45), SPID60=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30) +(15\*PID45) +(15\*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.

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

SPID5
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray40.357.7Not reportedNot reportedNot reported
Placebo32.052.1Not reportedNot reportedNot reported
SPID10
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray115.0130.7Not reportedNot reportedNot reported
Placebo81.1108.0Not reportedNot reportedNot reported
SPID15
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray220.6209.7Not reportedNot reportedNot reported
Placebo150.3172.5Not reportedNot reportedNot reported
SPID45
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray1122.0731.9Not reportedNot reportedNot reported
Placebo667.0614.5Not reportedNot reportedNot reported
SPID60
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fentanyl Sublingual Spray1649.01016.2Not reportedNot reportedNot reported
Placebo965.7862.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.7
        value
        40.3
      2. group Id
        OG001
        spread
        52.1
        value
        32.0
    title
    SPID5
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        130.7
        value
        115.0
      2. group Id
        OG001
        spread
        108.0
        value
        81.1
    title
    SPID10
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        209.7
        value
        220.6
      2. group Id
        OG001
        spread
        172.5
        value
        150.3
    title
    SPID15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        731.9
        value
        1122.0
      2. group Id
        OG001
        spread
        614.5
        value
        667.0
    title
    SPID45
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1016.2
        value
        1649.0
      2. group Id
        OG001
        spread
        862.1
        value
        965.7
    title
    SPID60
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      92
    units
    Participants
description
Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5\*PID5), SPID10=(5\*PID5)+(5\*PID10), SPID15=(5\*PID5)+(5\*PID10)+(5\*PID15), SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30), SPID45=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30)+(15\*PID45), SPID60=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30) +(15\*PID45) +(15\*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.
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
Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode
title
Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice