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Phase II study to evaluate the preventive effect and safety of lubiprostone in opioid-induced constipation

A Phase II Study of the Preventive Effectiveness and Safety of Lubiprostone in Opioid-Induced Constipation (OIC) Caused by Opioid Analgesics for the Treatment of Cancer Pain

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051230150
Enrollment
37
Registered
2023-12-22
Start date
2025-01-10
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 pain cancer pain

Interventions

On the day opioid analgesics are started, Lubiprostone is administered orally at a dose of 24 mcg twice daily after breakfast and dinner for 1 week

Sponsors

Kuriyama Toshiyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. cancer patients over 18 years of age who are involved with the Palliative Care Team and Palliative Care Unit 2. patients who are receiving opioid analgesics (morphine, oxycodone, hydromorphone, tapentadol, fentanyl, tramadol, codeine phosphate) for the first time for cancer pain

Exclusion criteria

Exclusion criteria: 1. patients with diagnosed or suspected intestinal obstruction 2. patients who are unable to take oral intake 3. patients with ECOG PS4 4. patients who have difficulty in obtaining written consent and completing the questionnaire 5. patients with Child-Pugh B or C 6. patients with eGFR less than 30 mL/min/1.73 m2 7. Patients with a history of allergy or contraindication to Lubiprostone 8. patients with diarrhea (Bristol stool scale 6 or 7) 9. patients with a history of irritable bowel syndrome

Design outcomes

Primary

MeasureTime frame
Percentage of patients diagnosed with opioid-induced constipation (OIC) by ROME IV criteria one week after starting the study

Secondary

MeasureTime frame
1. change in frequency of spontaneous defecation (/week) during the first week of the study 2. percentage of patients using rescue laxatives during the study period 3. percentage of patients experiencing nausea, vomiting, or diarrhea during the study period 4. other adverse events that may be influenced by the study drug

Contacts

Public ContactToshiyuki Kuriyama

Wakayama Medical University

kuriyama@wakayama-med.ac.jp+81-734410611

Outcome results

None listed

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