Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
hydrocodone/acetaminophen · 3 trials · 2 indications
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 48 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
| Arm | Type | Description |
|---|---|---|
| Open-label Hydrocodone/Acetaminophen Extended Release | EXPERIMENTAL | Hydrocodone/acetaminophen extended release, 2 tablets twice daily |
| Double-blind Hydrocodone/Acetaminophen Extended Release | EXPERIMENTAL | Hydrocodone/acetaminophen extended release, 1 tablet twice daily |
| Double-blind Placebo | PLACEBO_COMPARATOR | Placebo, 1 tablet twice daily |
| Placebo | PLACEBO_COMPARATOR | placebo, 1 oral tablet every 12 hours |
| Hydrocodone/Acetaminophen Extended Release | EXPERIMENTAL | hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours |
| Acetaminophen | ACTIVE_COMPARATOR | 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). |
| Morphine Extended Release | ACTIVE_COMPARATOR | 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). |
| Morphine Extended Release / Acetaminophen | ACTIVE_COMPARATOR | 1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). |
| Name | Type | Description |
|---|---|---|
| hydrocodone/acetaminophen extended release | DRUG | - |
| Placebo | DRUG | - |
| Acetaminophen | DRUG | - |
| Morphine Extended Release | DRUG | - |
Inclusion Criteria: Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration Exclusion Criteria: Subjects with a history of surgical or invasive intervention
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