PHarmacological Audit study of Safety and Effectiveness in Real world: Naldemedine for Opioid-Induced Constipation study

PHarmacological Audit study of Safety and Effectiveness in Real world: Naldemedine for Opioid-Induced Constipation study - Phase-R OIC study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031381

Enrollment

200

Registered

2018-03-01

Start date

2018-05-01

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

opioid-induced constipation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) adult patients with cancer receiving care from palliative care teams or in palliative care units 2) scheduled naldemedine administration for opioid-induced constipation 3) planned to receive sustained doses of opioid and laxatives

Exclusion criteria

Exclusion criteria: 1) patients with suspected malignant bowel obstruction, or previous history of malignant bowel obstruction and high recurrence risk 2) prior naldemedine administration

Design outcomes

Primary

Measure	Time frame
Spontaneous bowel movements within 24 hours after first naldemedine administration	—

Secondary

Measure	Time frame
Number of spontaneous bowel movements during 1 week after first naldemedine administration	—

Countries

Japan

Contacts

Public ContactKeisuke Ariyoshi

JORTC Data Center Department of Data Management

keisuke.ariyoshi@jortc.jp03-5604-9850

Outcome results