cancer pain cancer pain
Conditions
Interventions
To continuous intravenous infusion of hydromorphone hydrochloride on fixed dose during 72 hours or more
Sponsors
NAKATANI Toshihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese cancer inpatient with cancer pain 2) Patient who are under pain controlled by continuous intravenous infusion of hydromorphone hydrochloride 3) 20 years or older at the time of informed consent
Exclusion criteria
Exclusion criteria: 1)Patient of history of hypersensitivity for hydromorphone 2) Patient with the symptom and finding of corresponding to contraindication or principle contraindication in package insert. 3)Decreased liver function equivalent Grade 3 or more and albumin decrease (less than 20 g/L) in common Terminology Criteria for Adverse Events v5.0 4)Patient who has received a drug that affect the loss of creatinine in serum within 14 days before from the day before registration 5)Patient with hemodialysis and peritoneal dialysis. 6) Patient under pregnancy and nursing. 7) Patients with participating or planed in intervention clinical trials 8)Patient who are judged by physicians to be ineligible subjects of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total body clearance at steady state of hydromorphone | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Pharmacokinetic (PK) endpoint 1.The concentration of hydromorphone and the metabolite (hydromorphone-3-glucuronide: H3G) in plasma 2.Renal clearance of hydromorphone (free body) and the metabolite (H3G) and the urinary excretion rate of those. 3.The cumulative fraction of dose excreted in urine and the renal clearance of hydromorphone and H3G 2)Exploratory end-point The concentration of the urine toxin in plasma 3)Safety endpoint Adverse event | — |
Contacts
Public ContactToshihiko NAKATANI
Shimane University Hospital
Outcome results
None listed