OLZOINV study

Phase 2

Recruiting

• Conditions: Opioid-induced nausea and vomiting

• Registration Number: JPRN-jRCTs031220008
• Lead Sponsor: Satomi Eriko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Histologically or clinically malignant disease
-An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
-Patients with moderate to severe cancer pain needed to treat with opioid analgesics as morphine, oxycodone,hydromorphone, etc
-Ability to provide informed written consent
-An age of > =18 years
-Capable to take medicine orally
-A life expectancy of 4 weeks or longer
-Able to complete study assessments and complying with the study procedures

Exclusion Criteria

-Diabetes mellitus
-Had vomiting or nausea (> =CTCAE grade2)
-Symptomatic intracranial disease as brain metastasis,nerve dissemination
-Had received radiotherapy to the head, abdomen, or pelvis within 6 days before and during the study period
-Had received new drugs with emetic or antiemetic action within 48 hours before study initiation
-Had received regular strong opioid analgesics within 1 month before study initiation
-Had a history of hypersensitivity or any contraindication to olanzapine
-Had received new chemotherapeutic agents within 1 week before treatment with the study drug and during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete control rate during the 5 days of treatment with initiation of olanzapine.

Secondary Outcome Measures

Name	Time	Method
1) Complete Response Rate during the 5 days of treatment with initiation of olanzapine.<br>2) Total Control Rate during the 5 days of treatment with initiation of olanzapine.<br>3) Time to the first emetic episode<br>4) Time to the first rescue antiemetics administration<br>5) Time to Treatment Failure<br>6) The proportion of patients who had no emetic episode during the study period<br>7) The cumulative number of emetic episodes in patients who had at least one emetic episode during the study period<br>8) The proportions of patients with no nausea, no moderate nausea (CTCAE grade2>)<br>9) Nausea numerical rating scale<br>10) The proportion of patients who had no rescue antiemetics during the study period<br>11) The cumulative number of rescues antiemetics during the study period<br>12) Opioid daily dose (including rescue opioid)<br>13) Oral intake<br>14) FACT-G<br>15) Pain numerical rating scale<br>16) ESAS-j<br>17) Adverse events (CTCAE ver.5)<br>18) Patient satisfaction<br>19) Feasibility