Approval Probability
TA Base Rate
Adjusted LOA
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Hydromorphone · 2 trials · 2 indications
The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.
| Arm | Type | Description |
|---|---|---|
| OROS Hydromorphone hydrochloride (HCl) | EXPERIMENTAL | OROS Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioid dose. |
| Oxycodone HCl Controlled release (CR) | ACTIVE_COMPARATOR | Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose. |
| Hydromorphone 16 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Hydromorphone HCl | DRUG | Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of Titration phase and 28 days of Maintenance phase. Starting dose will be based on participant's previous daily opioid dose. |
| Oxycodone HCl CR | DRUG | Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose. |
| Placebo | DRUG | Placebo will be administered to the participants receiving hydromorphone HCl or oxycodone HCl CR along with the study treatment to maintain necessary blinding. |
| Hydromorphone 16 mg | DRUG | type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg. |
Inclusion Criteria: * Participants receiving strong oral or transdermal (through the skin) opioid analgesics with inadequate control of moderate to severe (very serious, life threatening) cancer pain or who presented with cancer pain and will be eligible to move to Step 3 of the WHO analgesic ladde...
Hydromorphone is an opioid analgesic being studied for the management of pain, including cancer-related pain. It is also used in clinical studies involving healthy volunteers to assess pharmacokinetic profiles. The drug is currently in clinical development for these pain-related indications.
Hydromorphone is being developed by Johnson & Johnson, a company publicly traded under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's efficacy and safety in pain management and its pharmacokinetic profile in healthy volunteers.
Hydromorphone is in Phase 1 clinical development, based on the most recent trial data. While one completed Phase 3 trial exists, the drug's current development stage is Phase 1, and it remains investigational and not yet approved for any indication.
Hydromorphone has been studied in two completed clinical trials. NCT01205126 was a Phase 3 study in 260 participants with cancer-related pain in China. NCT01487564 was a Phase 1 pharmacokinetic study in 29 healthy Taiwanese participants with different UGT2B7 genotypes.
Yes, Hydromorphone is the same as OROS Hydromorphone, which refers to the oral osmotic therapeutic system formulation of the drug. Clinical trials have evaluated this formulation for cancer-related pain and for pharmacokinetic profiling in healthy volunteers.