臨床研究等提出・公開システム

Date of registration	Dec. 22, 2023
Last modified on	Feb. 25, 2025
Trial ID	jRCTs051230150

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

Contact for Scientific Queries	Name	Kuriyama Toshiyuki
	Affiliation	Wakayama Medical University Hospital Department of Anesthesiology
	Address	811-1, Kimiidera, Wakayama City, Wakayama 641-0012, Japan
	Telephone	+81-734410611
	E-mail	kuriyama@wakayama-med.ac.jp
Contact for Public Queries	Name	Kuriyama Toshiyuki
	Affiliation	Wakayama Medical University
	Address	811-1 Kimiidera, Wakayama-shi, Waklayama-Prefecture
	Telephone	+81-734410611
	E-mail	kuriyama@wakayama-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 22, 2023
Actual date of first enrollment		Jan. 10, 2025
Target sample size		37
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion 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	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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		cancer pain
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
Health Condition(s) Keyword		cancer pain
Primary Outcome(s)		Percentage of patients diagnosed with opioid-induced constipation (OIC) by ROME IV criteria one week after starting the study
Secondary Outcome(s)		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

Name of Certified Review Board	Wakayama Medical University Certified Review Board
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan, Wakayama
Telephone	+81-73-441-0896
E-Mail	wa-rinri@wakayama-med.ac.jp
Approval Status	Approval
Date of approval	Dec. 08, 2023

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 25, 2025	(this page)	Changes
2	Sept. 19, 2024	Detail	Changes
1	Dec. 22, 2023	Detail

List of change history