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

JRCT ID: jRCTs051230150

Registered date:22/12/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: cancer pain
• Date of first enrollment: 22/12/2023
• Target sample size: 37
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: Percentage of patients diagnosed with opioid-induced constipation (OIC) by ROME IV criteria one week after starting the study

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. cancer patients over 18 years of age who are involved with the Palliative Care Team and Palliative Care Unit
2. patients not currently receiving opioid analgesics
3. patients who are receiving opioid analgesics (morphine, oxycodone, hydromorphone, tapentadol, fentanyl, tramadol, codeine phosphate) for the first time for cancer pain

Exclude 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

Related Information

• Primary Sponsor: Kuriyama Toshiyuki