Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
oxycodone IR · 2 trials · 4 indications
SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where "0" is no pain and "10" is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).
The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief. The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Tapentadol IR (CG5503) 50mg for 14 days |
| 002 | EXPERIMENTAL | Tapentadol IR (CG5503) 75mg for 14 days |
| 003 | ACTIVE_COMPARATOR | oxycodone IR 10mg for 14 days |
| 004 | PLACEBO_COMPARATOR | placebo 1 capsule for 14 days |
| 005 | EXPERIMENTAL | Tapentadol ER (CG5503) flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day) |
| 006 | ACTIVE_COMPARATOR | oxycodone CR flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day) |
| 007 | PLACEBO_COMPARATOR | placebo Tablets and capsules 2 x a day for 28 days |
| Name | Type | Description |
|---|---|---|
| oxycodone CR | DRUG | flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day) |
| oxycodone IR | DRUG | 10mg for 14 days |
| Tapentadol ER (CG5503) | DRUG | flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day) |
| Tapentadol IR (CG5503) | DRUG | 50mg for 14 days |
| placebo | DRUG | 1 capsule for 14 days |
| tapentadol IR | DRUG | 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days |
Inclusion Criteria: * A clinical diagnosis of osteoarthritis of the hip or knee * End-stage degenerative joint disease * Eligibility for primary unilateral total or partial joint replacement surgery * Pain level moderate to severe and at such a level as to require daily doses of an opioid analgesic...