TriangleNCT01029652 · OUTCOME
Percentage of Participants Who Took Rescue Medication
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- during 12 weeks core, 24 weeks overall
What was measured
Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration.
Analysis population: The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. "12 weeks:Core" consisted of patients taking rescue medication during baseline flare of Core study and "24 weeks:Overall" consisted of patients who took rescue medication during last post-baseline flare during 24 weeks.
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
12 weeks :Core (N=113, 115)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | 31.0 | Not reported | NotEst | NotEst | Not reported |
| Triamcinolone Acetonide 40 mg | 52.2 | Not reported | 30 | NotEst | Not reported |
24 weeks: Overall (N=35, 43)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | 48.6 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide 40 mg | 44.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- NotEst
- upper Limit
- NotEst
- value
- 31.0
- group Id
- OG001
- lower Limit
- 30
- upper Limit
- NotEst
- value
- 52.2
- title
- 12 weeks :Core (N=113, 115)
- categories
- measurements
- group Id
- OG000
- value
- 48.6
- group Id
- OG001
- value
- 44.2
- title
- 24 weeks: Overall (N=35, 43)
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration.
- 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
- NUMBER
- population Description
- The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. "12 weeks:Core" consisted of patients taking rescue medication during baseline flare of Core study and "24 weeks:Overall" consisted of patients who took rescue medication during last post-baseline flare during 24 weeks.
- reporting Status
- POSTED
- time Frame
- during 12 weeks core, 24 weeks overall
- title
- Percentage of Participants Who Took Rescue Medication
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice