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Also known as OROS hydromorphone HCl
OROS hydromorphone · 2 trials · 3 indications
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...
OROS hydromorphone is an investigational, sustained-release oral formulation of the opioid hydromorphone developed by Johnson & Johnson (ticker JNJ). It uses an osmotic controlled-release delivery system to provide extended pain relief. It is a small molecule being studied in Phase 3 clinical development for the treatment of moderate to severe pain.
OROS hydromorphone is being studied for the treatment of moderate to severe pain. Clinical trials have evaluated it in patients with chronic noncancer pain and in patients with moderate to severe pain caused by osteoarthritis of the hip or knee. It is an investigational therapy and has not been established as an approved treatment.
OROS hydromorphone is developed by Johnson & Johnson, which trades under the ticker JNJ. The company has sponsored the Phase 3 clinical program evaluating this sustained-release oral opioid formulation in patients with moderate to severe pain, including chronic noncancer pain and osteoarthritis-related pain.
OROS hydromorphone is in Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. The program has enrolled a total of 792 patients across randomized, double-blind, placebo-controlled studies. It remains an investigational drug and is not an approved product.
Two completed Phase 3 trials have evaluated OROS hydromorphone. NCT00980798 was a placebo-controlled trial in patients with moderate to severe pain from osteoarthritis of the hip or knee, enrolling 288 patients. NCT00261495 studied sustained-release hydromorphone in 504 patients with chronic noncancer pain. Both were randomized, double-blind, and placebo-controlled.
Yes, OROS hydromorphone and OROS hydromorphone HCl refer to the same investigational product. The HCl designation indicates the hydrochloride salt form of hydromorphone used in the osmotic controlled-release formulation developed by Johnson & Johnson for the treatment of moderate to severe pain.