18 and older, any sex, with Breakthrough Cancer Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in ConsultationPrimary· Month 1
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Group
Value
95% CI
Cohort 1
14.3
13.2 – 15.4
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in ConsultationPrimary· Month 1
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Group
Value
95% CI
Cohort 1
48.3
45.3 – 51.2
Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in ConsultationSecondary· Month 1
Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Group
Value
95% CI
Cohort 1
105
Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in ConsultationSecondary· Month 1
Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Group
Value
95% CI
Cohort 1
19.3
16.0 – 22.6
Pain Characterization With the Alberta Breakthrough Pain AssessmentSecondary· Month 1
The Alberta Breakthrough Pain Assessment Tool (ABPAT) consisted of a participant's self-reporting section (15 questions) out of which 4 questions of the tool were not included as they were related to the treatment for breakthrough cancer pain. The questions included: Q1-Relationship to baseline pain, Q2a-Last time experienced, Q3b-Frequency, Q4b-Intensity of pain at peak, Q5-Location (most frequent - ≥5%), Q6-Quality (those present in ≥20%), Q7-Time from onset to peak intensity, Q8-Time from onset \[take medication\] to end of episode, Q9-Cause(s) (triggers) (Those present in ≥20%), Q10-Predic
Q1, Brief Flare-up of Baseline Pain
Group
Value
95% CI
Cohort 1
53.2
Q1, Different from Baseline Pain
Group
Value
95% CI
Cohort 1
36.3
Q1, Not Sure
Group
Value
95% CI
Cohort 1
10.5
Q2a, Today
Group
Value
95% CI
Cohort 1
57.7
Q2a, Yesterday
Group
Value
95% CI
Cohort 1
33.0
Q2a, Before then
Group
Value
95% CI
Cohort 1
9.3
Q3b, Usual
Group
Value
95% CI
Cohort 1
62.6
Q3b, Better
Group
Value
95% CI
Cohort 1
8.4
Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire ScoreSecondary· Month 1
The BPI questionnaire was used to assess the pain intensity (4 items) and interference with activities of daily living (7 items). Each item was given a score on a numerical scale from 0 (no pain/interference with activities of daily living) to 10 (worst pain imaginable/maximum impact on activities of daily living). The total score for pain intensity is the average of the four pain items. The total score of pain interference is the average score of the seven interference items. The higher score represents high impact.
Pain Severity
Group
Value
95% CI
Cohort 1
5.33
± 1.78
Pain Interference
Group
Value
95% CI
Cohort 1
6.07
± 2.05
Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire ScoreSecondary· Month 1
The SF-12 health questionnaire is a 12 question assessment of functional health and well-being. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 (poor ment
Physical Component SF-12
Group
Value
95% CI
Cohort 1
28.53
± 7.97
Mental Component SF-12
Group
Value
95% CI
Cohort 1
36.87
± 9.51
Participant's Performance as Assessed by the Karnofsky Scale ScoreSecondary· Month 1
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (participant asymptomatic with no evidence of illness). Higher score means higher ability to perform daily tasks. Participants with missing values in the Karnofsky scale were assigned to the worst score of 0, however, in these cases it is not 'death'.
Score 0
Group
Value
95% CI
Cohort 1
0.2
Score 10
Group
Value
95% CI
Cohort 1
0.5
Score 20
Group
Value
95% CI
Cohort 1
0.8
Score 30
Group
Value
95% CI
Cohort 1
1.4
Score 40
Group
Value
95% CI
Cohort 1
2.2
Score 50
Group
Value
95% CI
Cohort 1
2.9
Score 60
Group
Value
95% CI
Cohort 1
6.7
Score 70
Group
Value
95% CI
Cohort 1
11.9
Sponsor's own description
The purpose of this study is to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an unselected, representative cohort of cancer outpatients with or without pain who attend consultations.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 22 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02899884.