Phase II study to evaluate the preventive effect and safety of lubiprostone in opioid-induced constipatio
- Conditions
- cancer pain
- Registration Number
- JPRN-jRCTs051230150
- Lead Sponsor
- Kuriyama Toshiyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 37
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients diagnosed with opioid-induced constipation (OIC) by ROME IV criteria one week after starting the study
- Secondary Outcome Measures
Name Time Method 1. change in frequency of spontaneous defecation (/week) during the first week of the study<br>2. percentage of patients using rescue laxatives during the study period<br>3. percentage of patients experiencing nausea, vomiting, or diarrhea during the study period<br>4. other adverse events that may be influenced by the study drug