TriangleNCT00538850 · OUTCOME
Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)
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
- Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode
What was measured
Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fentanyl Sublingual Spray | 640.3 | 458.8 | Not reported | Not reported | Not reported |
| Placebo | 399.6 | 391.2 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 458.8
- value
- 640.3
- group Id
- OG001
- spread
- 391.2
- value
- 399.6
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.
- 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
- Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode
- title
- Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)
- type
- PRIMARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice