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NCT01156142 · OUTCOME

Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash

Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy · Source last updated 2017-08-09

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 9 days

What was measured

The incidence of utilizing additional analgesics between 2 and 4 hours after the initial mouthwash will be compared between the arms by the Chi-square test .

Groups in this outcome

Arm I (Doxepin-Placebo)

Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.

Arm II (Placebo-Doxepin)

Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.

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

Analysis denominator · Participants

GroupSource count
Arm I (Doxepin-Placebo)69
Arm II (Placebo-Doxepin)71

Reported measurements

At 2 hours after the initial mouthwash
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Doxepin-Placebo)8.8Not reportedNot reportedNot reportedNot reported
Arm II (Placebo-Doxepin)2.9Not reportedNot reportedNot reportedNot reported
At 4 hours after the initial mouthwash
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Doxepin-Placebo)16.9Not reportedNot reportedNot reportedNot reported
Arm II (Placebo-Doxepin)14.5Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    At 2 hours after initial mouthwash
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1392
    statistical Method
    Chi-squared
  2. group Description
    At 4 hours after initial mouthwash
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6989
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Description
    At 2 hours after initial mouthwash
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1392
    statistical Method
    Chi-squared
  2. group Description
    At 4 hours after initial mouthwash
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6989
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8.8
      2. group Id
        OG001
        value
        2.9
    title
    At 2 hours after the initial mouthwash
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        16.9
      2. group Id
        OG001
        value
        14.5
    title
    At 4 hours after the initial mouthwash
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      71
    units
    Participants
description
The incidence of utilizing additional analgesics between 2 and 4 hours after the initial mouthwash will be compared between the arms by the Chi-square test .
groups
  1. description
    Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
    id
    OG000
    title
    Arm I (Doxepin-Placebo)
  2. description
    Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
    id
    OG001
    title
    Arm II (Placebo-Doxepin)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 9 days
title
Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice