Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00980798 | Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee | PHASE3 | COMPLETED | 288 | — | — | Oct 1, 2007 | Nov 1, 2008 | Apr 25, 2014 | 12 | Czechia, Romania +2 |
| NCT00261495 | A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain. | PHASE3 | COMPLETED | 504 | — | — | Mar 1, 2006 | Apr 1, 2008 | Jun 3, 2014 | 52 | Czechia, Denmark +8 |
The analgesic effect was assessed by the BPI item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine".
Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.
If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.
Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.
Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | OROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks |
| 002 | PLACEBO_COMPARATOR | Placebo placebo tablet once daily for 16 weeks |
| Oxycodone | ACTIVE_COMPARATOR | - |
| OROS hydromorphone HCl | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| OROS hydromorphone HCl | DRUG | 4 to 32 mg taken orally once daily for 16 weeks |
| Placebo | DRUG | placebo tablet once daily for 16 weeks |
| Oxycodone | DRUG | 10, 20, or 40 mg twice a day for 52 weeks (flexible dosing) |
Inclusion Criteria: * Documented Osteoarthritis of the hip or knee * Chronic pain for more than 3 months treated with daily analgesic for the last month * Moderate to severe OA pain of the target joint, which cannot be adequately treated with non-steroidal anti-inflamatory drugs or paracetamol * Mo...