The Equivalent Doses Between Sustained Releasing Oxycodone And Transdermal Fentanyl Patch In Opioid Rotation. -A multi-center, observational study-

The Equivalent Doses Between Sustained Releasing Oxycodone And Transdermal Fentanyl Patch In Opioid Rotation. -A multi-center, observational study- - TITRATION study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015050

Enrollment

Registered

2014-09-16

Start date

2014-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer patients

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patient agreed the participation in writing. 2. Age older than 20 and younger than 75. 3. The patient is informed having cancer. 4. The patient NOT plans any operation, radiation therapy and anticancer drug during the clinical research. 5. The patient is administered oxycodone sustained-release product (commercial name: OXC). 6. The patient is ingested oxycodone sustained-release product more than 20mg and less than 60mg. 7. The patient plans the rotation from oxycodone sustained-release product to fentanyl patch. 8. The patient is expected to be alive longer than a month. 9. Karnofskys Performance status more than 40 and less than 100. 10. The patient keeps; WBC is more than 2000/mm3 and less than 12000/mm3 PLT is more than 50000/mm3 Hb is more than 8.0g/dL Cre is less than 1.5mg/dL AST is less than 100IU/L ALT is less than 100IU/L T-bil is less than 2.0mg/dL 11. The doctor judged the patient is able to participate this research.

Exclusion criteria

Exclusion criteria: 1. the hypersensitiveness to silicone 2. serious respiratory depression or serious chronic obstructive pulmonary disease 3. under the attack of bronchial asthma 4. chronic pulmonary disease with sequential heart failure 5. increased intracranial pressure and disturbance of consciousness 6. the dermatosis on the skin attaching medicine like eczema or atopic allergy 7. the fever over 40 degree Celsius 8. the pregnant women, the nursing women or the women possibly in pregnant 9. the patient giving the reversal agent of opioid receptor like pentazocine or buprenorphine within 2 days before the day starts clinical research or the patient expected giving the reversal agent 10. the lack of judgment ability

Design outcomes

Primary

Measure	Time frame
The success rate of opioid rotation for 4 cycles	—

Secondary

Measure	Time frame
Pain scale (Numerical Rating Scale) Adverse events (CTCAE v4.0) QOL (EORTC-PAL15) Frequency of rescue dose Opioid preference	—

Countries

Japan

Contacts

Public ContactHiroto Ishiki

Research Hospital, The Institute of Medical Science, The University of Tokyo Department of Palliative Medicine

ishiki-tky@umin.ac.jp03-3443-8111

Outcome results