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Prospective Trial of Efficacy of Naldemedine for Opioid-Induced Constipation in Patients with Advanced Pancreatic Cancer: Quality of Life survey

Prospective Trial of Efficacy of Naldemedine for Opioid-Induced Constipation in Patients with Advanced Pancreatic Cancer: Quality of Life survey - Efficacy of Naldemedine for Opioid-Induced Constipation: QOL survery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030219
Enrollment
20
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. QOL questionnaire perform at the start of naldemedine and two weeks after commencement.

Sponsors

Kitasato University School of Medicine Department of Gastroenterology
Lead Sponsor

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

MeasureTime frame
Change of QOL score at 2 weeks after treatment

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