TriangleNCT00538850 · OUTCOME
Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- 30 through 60 minutes after dosing for each pain episode
What was measured
Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.
Analysis population: Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Groups in this outcome
Fentanyl Sublingual Spray
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.
Placebo
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.
| Group | Source count |
|---|---|
| Fentanyl Sublingual Spray | 92 |
| Placebo | 92 |
Reported measurements
30 minutes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fentanyl Sublingual Spray | 2.8 | 0.8 | Not reported | Not reported | Not reported |
| Placebo | 2.0 | 0.8 | Not reported | Not reported | Not reported |
60 minutes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fentanyl Sublingual Spray | 3.1 | 0.8 | Not reported | Not reported | Not reported |
| Placebo | 2.2 | 0.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.8
- value
- 2.8
- group Id
- OG001
- spread
- 0.8
- value
- 2.0
- title
- 30 minutes
- categories
- measurements
- group Id
- OG000
- spread
- 0.8
- value
- 3.1
- group Id
- OG001
- spread
- 0.8
- value
- 2.2
- title
- 60 minutes
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.
- dispersion Type
- Standard Deviation
- groups
- 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
- OG000
- title
- Fentanyl Sublingual Spray
- 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
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
- reporting Status
- POSTED
- time Frame
- 30 through 60 minutes after dosing for each pain episode
- title
- Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice