Multicenter Prospective Trial of Efficacy of Naldemedine for Opioid-Induced Constipation in Patients with Advanced Pancreatic Cancer

Multicenter Prospective Trial of Efficacy of Naldemedine for Opioid-Induced Constipation in Patients with Advanced Pancreatic Cancer - Efficacy of Naldemedine for Opioid-Induced Constipation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030218

Enrollment

Registered

2017-12-04

Start date

2018-02-01

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

Naldemedine is administered orally once daily at a dose of 0.2mg/d for 14 consecutive days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients of pancreatic cancer with OIC receiving treatment by opioid for 2 weeks or more against cancer pain 2. less than three spontaneous bowel movements during a week before entry 3. patients who understand sufficiently the study to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. presence or suspicion of gastrointestinal stricture 2. difficult ingestion 3. allergy of naldemedine 4. severe mental illness 5. unsuitable case

Design outcomes

Primary

Measure	Time frame
Proportion of spontaneous bowel movement responders during the 2-week treatment period.	—

Countries

Japan

Contacts

Public ContactKosuke Okuwaki

Kitasato University School of Medicine Department of Gastroenterology

kokuwaki@kitasato-u.ac.jp81-42-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026