PK study of hydromorphone

JRCT ID: jRCT1061190042

Registered date:26/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cancer pain
• Date of first enrollment: 08/04/2020
• Target sample size: 48
• Study type: Interventional
• Intervention(s): To continuous intravenous infusion of hydromorphone hydrochloride on fixed dose during 72 hours or more

Outcome(s)

• Primary Outcome: Total body clearance at steady state of hydromorphone

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: NAKATANI Toshihiko
• Source(s) of Monetary Support: DAIICHI SANKYO COMPANY, LIMITED