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NCT04162873 · OUTCOME

Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Pain Control Questionnaire.

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer · Source last updated 2025-02-12

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

Measure
MEAN
Unit
score on the pain control questionnaire
Interval / dispersion
Standard Deviation
Time frame
post-surgery (up to 29 days from surgery) and end of treatment (up to 5 months from surgery)

What was measured

Patient satisfaction was assessed with a pain control questionnaire. The participants were asked questions about their pain satisfaction over the last seven days. The pain control questionnaire was scored from 0-100, with smaller values indicating poor pain control satisfaction and larger values indicating excellent pain control satisfaction. This outcome was assessed at post-surgery and end of treatment for up to 5 months

Analysis population: One participant on the Celcoxib Arm was not evaluable for this endpoint.

Groups in this outcome

Celecoxib Arm

Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

Placebo Arm

Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Celecoxib Arm4
Placebo Arm7

Reported measurements

Post-Operation
Values in score on the pain control questionnaire · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm79.8617.77Not reportedNot reportedNot reported
Placebo Arm96.825.42Not reportedNot reportedNot reported
End of Treatment
Values in score on the pain control questionnaire · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm80.5521.52Not reportedNot reportedNot reported
Placebo Arm88.8913.61Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.77
        value
        79.86
      2. group Id
        OG001
        spread
        5.42
        value
        96.82
    title
    Post-Operation
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.52
        value
        80.55
      2. group Id
        OG001
        spread
        13.61
        value
        88.89
    title
    End of Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Patient satisfaction was assessed with a pain control questionnaire. The participants were asked questions about their pain satisfaction over the last seven days. The pain control questionnaire was scored from 0-100, with smaller values indicating poor pain control satisfaction and larger values indicating excellent pain control satisfaction. This outcome was assessed at post-surgery and end of treatment for up to 5 months
dispersion Type
Standard Deviation
groups
  1. description
    Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    OG000
    title
    Celecoxib Arm
  2. description
    Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    OG001
    title
    Placebo Arm
param Type
MEAN
population Description
One participant on the Celcoxib Arm was not evaluable for this endpoint.
reporting Status
POSTED
time Frame
post-surgery (up to 29 days from surgery) and end of treatment (up to 5 months from surgery)
title
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Pain Control Questionnaire.
type
SECONDARY
unit Of Measure
score on the pain control questionnaire

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

Preserved source evidence · Not medical advice