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Label indication Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone Hydrochloride Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA label
Also known as Hydromorphone HCl
Hydromorphone · 1 trial · 1 indication
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. |
| 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. |
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 used to treat pain. It is being studied in a Phase 3 trial for cancer related pain. The drug is a small molecule and is also known as Hydromorphone HCl or Hydromorphone 16 mg.
Hydromorphone works as an agonist at the mu opioid receptor, which is encoded by the OPRM1 gene. By activating this receptor, it produces analgesic effects. This mechanism is characteristic of opioid pain medications.
Hydromorphone is developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company is conducting clinical development of the drug for pain indications.
Hydromorphone is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for the studied indication. The Phase 3 trial has been completed.
Hydromorphone has been studied in a Phase 3 trial, NCT01205126, titled 'An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain.' This completed trial enrolled 260 participants in China.
Yes, Hydromorphone is also known as Hydromorphone HCl and Hydromorphone 16 mg. These names refer to the same active drug, which is a small molecule agonist of the OPRM1 receptor.