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NCT04608773 · BASELINE

Baseline characteristics

Blinded Dry Mouth Spray Crossover Study · Source last updated 2024-02-01

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

denoms
  1. counts
    1. group Id
      BG000
      value
      69
    2. group Id
      BG001
      value
      60
    3. group Id
      BG002
      value
      129
    units
    Participants
groups
  1. description
    The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
    id
    BG000
    title
    Biotene Spray, Followed by Refresh Spray
  2. description
    The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
    id
    BG001
    title
    Refresh Spray, Followed by Biotene Spray
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          63
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          26
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          103
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          124
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only participants who completed the protocol were included in the analysis.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          129
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.6
          value
          44.0
        2. group Id
          BG001
          spread
          21.8
          value
          39.2
        3. group Id
          BG002
          spread
          21.0
          value
          42.4
    description
    Patients responded to electronic survey; the questionnaire included continuous variables derived from the 100mm visual analog scale (VAS). "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Drymouth baseline
    unit Of Measure
    units on a scale
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      69
    2. group Id
      BG001
      value
      60
    3. group Id
      BG002
      value
      129
    units
    Participants
groups
  1. description
    The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
    id
    BG000
    title
    Biotene Spray, Followed by Refresh Spray
  2. description
    The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
    id
    BG001
    title
    Refresh Spray, Followed by Biotene Spray
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          63
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          26
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          103
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          124
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only participants who completed the protocol were included in the analysis.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          129
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.6
          value
          44.0
        2. group Id
          BG001
          spread
          21.8
          value
          39.2
        3. group Id
          BG002
          spread
          21.0
          value
          42.4
    description
    Patients responded to electronic survey; the questionnaire included continuous variables derived from the 100mm visual analog scale (VAS). "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Drymouth baseline
    unit Of Measure
    units on a scale

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

Preserved source evidence · Not medical advice