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NCT00538850 · FLOW

Participant flow

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.

groups
  1. description
    In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
    id
    FG000
    title
    Fentanyl Sublingual Spray - Titration
  2. 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
    FG001
    title
    Fentanyl Sublingual Spray - Double-blind
  3. 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
    FG002
    title
    Placebo - Double-blind
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. comment
        There were no participants in this reporting group in the titration period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        There were no participants in this reporting group in the titration period.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        98
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Titration Period
  2. milestones
    1. achievements
      1. comment
        There were no participants in this reporting group in the double-blind period.
        group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        98
      3. comment
        There were no participants in this reporting group in the double-blind period.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        95
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Fentanyl Sublingual Spray - Double-blind
  3. milestones
    1. achievements
      1. comment
        There were no participants in this reporting group in the double-blind period.
        group Id
        FG000
        num Subjects
        0
      2. comment
        There were no participants in this reporting group in the double-blind period.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        98
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        95
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Placebo - Double-blind
pre Assignment Details
As there are dozens, if not hundreds, of cross-over sequences during the double-blind period of this study, instead of reporting participant flow for each of the cross-over sequences, participant flow is reported separately for the fentanyl and placebo groups.
Complete source fields
groups
  1. description
    In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
    id
    FG000
    title
    Fentanyl Sublingual Spray - Titration
  2. 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
    FG001
    title
    Fentanyl Sublingual Spray - Double-blind
  3. 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
    FG002
    title
    Placebo - Double-blind
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. comment
        There were no participants in this reporting group in the titration period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        There were no participants in this reporting group in the titration period.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        98
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Titration Period
  2. milestones
    1. achievements
      1. comment
        There were no participants in this reporting group in the double-blind period.
        group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        98
      3. comment
        There were no participants in this reporting group in the double-blind period.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        95
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Fentanyl Sublingual Spray - Double-blind
  3. milestones
    1. achievements
      1. comment
        There were no participants in this reporting group in the double-blind period.
        group Id
        FG000
        num Subjects
        0
      2. comment
        There were no participants in this reporting group in the double-blind period.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        98
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        95
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Placebo - Double-blind
pre Assignment Details
As there are dozens, if not hundreds, of cross-over sequences during the double-blind period of this study, instead of reporting participant flow for each of the cross-over sequences, participant flow is reported separately for the fentanyl and placebo groups.

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Preserved source evidence · Not medical advice