TriangleNCT04162873 · OUTCOME
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on the pain intensity scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 29 days from the start of study treatment
What was measured
Assessment of subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough. The subjects rated their pain from 0-10 on the pain intensity scale. Scores are reported as means of the pain score with standard deviation. This outcome is reported scores collected at the post-surgery visit; 9 to 29 days after the start of study treatment.
Analysis population: One participant on the Celecoxib Arm withdrew consent from the study treatment before the Post-Operation visit and 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
While at Rest
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 4.63 | 2.29 | Not reported | Not reported | Not reported |
| Placebo Arm | 1.21 | 1.22 | Not reported | Not reported | Not reported |
With a Swallow
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 5.00 | 2.80 | Not reported | Not reported | Not reported |
| Placebo Arm | 1.64 | 2.46 | Not reported | Not reported | Not reported |
With a Cough
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 4.25 | 1.44 | Not reported | Not reported | Not reported |
| Placebo Arm | 1.79 | 2.80 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.29
- value
- 4.63
- group Id
- OG001
- spread
- 1.22
- value
- 1.21
- title
- While at Rest
- categories
- measurements
- group Id
- OG000
- spread
- 2.80
- value
- 5.00
- group Id
- OG001
- spread
- 2.46
- value
- 1.64
- title
- With a Swallow
- categories
- measurements
- group Id
- OG000
- spread
- 1.44
- value
- 4.25
- group Id
- OG001
- spread
- 2.80
- value
- 1.79
- title
- With a Cough
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Assessment of subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough. The subjects rated their pain from 0-10 on the pain intensity scale. Scores are reported as means of the pain score with standard deviation. This outcome is reported scores collected at the post-surgery visit; 9 to 29 days after the start of study treatment.
- 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 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
- reporting Status
- POSTED
- time Frame
- Up to 29 days from the start of study treatment
- title
- Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale.
- type
- SECONDARY
- unit Of Measure
- score on the pain intensity scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice