TriangleNCT04162873 · OUTCOME
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- MME/day
- Interval / dispersion
- Standard Deviation
- Time frame
- Post-Surgery (1-7 days) up to 7 days, Post-Surgery (1-14 days) up to 14 days, Post-Surgery (1-26 days) up to 26 days, Post-Surgery (1-35 days) up to 35 days, and End of Treatment up to 146 days.
What was measured
Narcotic consumption was assessed in daily total morphine equivalents averaged over a week. This outcome was assessed at 7 days after surgery and 35 days after surgery. Morphine equivalent dose (MED) is the amount of opioid prescription drugs a patient is taking per day. MED is the sum of the total morphine milligram equivalents (MMEs), a common unit for assessing milligrams of morphine, dose per day. The Post-Surgery (1-7 days) time point is MED from 1 to 7 days after surgery. The Post-Surgery (1-14 days) time point is MED from 1 to 14 days after surgery. The Post-Surgery (1-26 days) time point is MED from 1 to 26 days after surgery. The Post-Surgery (1-35 days) time point is MED from 1 to 35 days after surgery. The End of Treatment time point is MED from 1 to 146 days after surgery.
Analysis population: One participant on the Celecoxib Arm was not evaluable for this endpoint.
Groups in this outcome
Celecoxib Arm
Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Placebo Arm
Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
| Group | Source count |
|---|---|
| Celecoxib Arm | 4 |
| Placebo Arm | 7 |
Reported measurements
Post-Surgery (1-7 days)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 22.19 | 22.20 | Not reported | Not reported | Not reported |
| Placebo Arm | 28.73 | 34.51 | Not reported | Not reported | Not reported |
Post-Surgery (1-14 days)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 14.24 | 18.74 | Not reported | Not reported | Not reported |
| Placebo Arm | 20.18 | 28.78 | Not reported | Not reported | Not reported |
Post-Surgery (1-21 days)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 12.82 | 17.21 | Not reported | Not reported | Not reported |
| Placebo Arm | 15.85 | 25.01 | Not reported | Not reported | Not reported |
Post-Surgery (1-26 days)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 9.88 | 15.67 | Not reported | Not reported | Not reported |
| Placebo Arm | 13.46 | 22.54 | Not reported | Not reported | Not reported |
Post-Surgery (1-35 days)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 8.76 | 14.32 | Not reported | Not reported | Not reported |
| Placebo Arm | 12.14 | 20.91 | Not reported | Not reported | Not reported |
End of Treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 6.64 | 7.32 | Not reported | Not reported | Not reported |
| Placebo Arm | 11.02 | 16.96 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 22.20
- value
- 22.19
- group Id
- OG001
- spread
- 34.51
- value
- 28.73
- title
- Post-Surgery (1-7 days)
- categories
- measurements
- group Id
- OG000
- spread
- 18.74
- value
- 14.24
- group Id
- OG001
- spread
- 28.78
- value
- 20.18
- title
- Post-Surgery (1-14 days)
- categories
- measurements
- group Id
- OG000
- spread
- 17.21
- value
- 12.82
- group Id
- OG001
- spread
- 25.01
- value
- 15.85
- title
- Post-Surgery (1-21 days)
- categories
- measurements
- group Id
- OG000
- spread
- 15.67
- value
- 9.88
- group Id
- OG001
- spread
- 22.54
- value
- 13.46
- title
- Post-Surgery (1-26 days)
- categories
- measurements
- group Id
- OG000
- spread
- 14.32
- value
- 8.76
- group Id
- OG001
- spread
- 20.91
- value
- 12.14
- title
- Post-Surgery (1-35 days)
- categories
- measurements
- group Id
- OG000
- spread
- 7.32
- value
- 6.64
- group Id
- OG001
- spread
- 16.96
- value
- 11.02
- title
- End of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Narcotic consumption was assessed in daily total morphine equivalents averaged over a week. This outcome was assessed at 7 days after surgery and 35 days after surgery. Morphine equivalent dose (MED) is the amount of opioid prescription drugs a patient is taking per day. MED is the sum of the total morphine milligram equivalents (MMEs), a common unit for assessing milligrams of morphine, dose per day. The Post-Surgery (1-7 days) time point is MED from 1 to 7 days after surgery. The Post-Surgery (1-14 days) time point is MED from 1 to 14 days after surgery. The Post-Surgery (1-26 days) time point is MED from 1 to 26 days after surgery. The Post-Surgery (1-35 days) time point is MED from 1 to 35 days after surgery. The End of Treatment time point is MED from 1 to 146 days after surgery.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG000
- title
- Celecoxib Arm
- description
- Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Placebo Arm
- param Type
- MEAN
- population Description
- One participant on the Celecoxib Arm was not evaluable for this endpoint.
- reporting Status
- POSTED
- time Frame
- Post-Surgery (1-7 days) up to 7 days, Post-Surgery (1-14 days) up to 14 days, Post-Surgery (1-26 days) up to 26 days, Post-Surgery (1-35 days) up to 35 days, and End of Treatment up to 146 days.
- title
- Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo.
- type
- SECONDARY
- unit Of Measure
- MME/day
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice