TriangleNCT01029652 · OUTCOME
Time to Complete Resolution of Pain
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 7 days post-dose (randomization)
What was measured
Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined.
Analysis population: The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Groups in this outcome
Canakinumab 150 mg
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Triamcinolone Acetonide 40 mg
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
| Group | Source count |
|---|---|
| Canakinumab 150 mg | 113 |
| Triamcinolone Acetonide 40 mg | 115 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | NA | Not reported | NA | NA | The median time to complete resolution could not be estimated because \<50% of patients had a complete resolution during the time period. |
| Triamcinolone Acetonide 40 mg | NA | Not reported | NA | NA | The median time to complete resolution could not be estimated because \<50% of patients had a complete resolution during the time period. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median time to complete resolution could not be estimated because \<50% of patients had a complete resolution during the time period.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median time to complete resolution could not be estimated because \<50% of patients had a complete resolution during the time period.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
- id
- OG000
- title
- Canakinumab 150 mg
- description
- Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
- id
- OG001
- title
- Triamcinolone Acetonide 40 mg
- param Type
- MEDIAN
- population Description
- The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- 7 days post-dose (randomization)
- title
- Time to Complete Resolution of Pain
- type
- SECONDARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice