A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of the Preventive Effect of Naldemedine on Opioid-Induced Constipatio

Phase 2

• Conditions: neoplasms; Cancer, Opioid induced constipation; D009369

• Registration Number: JPRN-jRCTs031200397
• Lead Sponsor: Jun Hamano

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Cancer patients who are starting regular oral use of strong opioids (morphine, oxycodone,
hydromorphone) for the first time for cancer pain
2) Age 20 years or older (at the time of obtaining consent)
3) Patients who are able to take oral medications, food, and beverages
4) Patients who are considered capable of self-recording in the patient diary (proxy recording in the patient
diary is acceptable if the patient is capable of self-assessment).
5) Patients who are not expected to have a rapid change in their cancer condition during the study period.
6) Patients who have received sufficient explanation and written consent of their own free will to participate
in this study.

Exclusion Criteria

1) Patients with gastrointestinal obstruction or suspected gastrointestinal obstruction, or patients with
a history of gastrointestinal obstruction and a high risk of recurrence
2) Patients who have undergone surgery, radiotherapy, or procedures affecting gastrointestinal function
(e.g., nerve block) within 14 days prior to the date of enrollment, or who are scheduled to undergo such
procedures during the study period.
3) Patients with medically significant cardiovascular, respiratory, hepatic, or renal dysfunction based on
history, clinical laboratory values, electrocardiogram, or physical examination, who are judged inappropriate to participate in the study.
4) Patients who have received or are currently receiving naldemedine medication
5) Patients who have had severe diarrhea (more than 7 times a day) or who have had a stool extraction for constipation within the past 7 days
6) Patients who have used opioid patches or injectable opioids in the past 7 days.
7) Patients who have received cancer drug therapy that is certain to affect defecation within 14 days prior to the initial enrollment date, or who are scheduled to receive such therapy within the study period. Cancer
drug therapy that is certain to affect defecation will be defined as follows.
1.Initial administration of a therapeutic regimen containing irinotecan (CPT-11)
2.Other cancer drug therapy that is considered certain to affect defecation.
However, the following cases may be considered as not affecting defecation
a) Chemotherapy with the same regimen as the previous course or chemotherapy with the same drug and
dose, and there was no moderate or greater constipation or diarrhea (CTCAE v5.0 Grade 2 or higher)
during the previous course or previous chemotherapy.
b) Patients who have received oral anticancer agents (e.g. TS-1) daily and have not had moderate or severe constipation or diarrhea (CTCAE v5.0 Grade 2 or higher) for at least 1 week from the start of oral
chemotherapy to the start of study drug.
8) Pregnant or lactating patients
9) Patients with suspected hypersensitivity to opioid receptor antagonists such as naldemedine, naltrexone, methylnaltrexone, and naloxone.
10) Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for
participation in the study based on concomitant therapy or medical findings.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a Bowel Function Index of less than 28.8 on Day 14