JPRN-jRCTs051230150
Not yet recruiting
Phase 2
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
Kuriyama Toshiyuki0 sites37 target enrollmentDecember 22, 2023
Conditionscancer pain
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- cancer pain
- Sponsor
- Kuriyama Toshiyuki
- Enrollment
- 37
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 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
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
Outcomes
Primary Outcomes
Not specified
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