A proof of concept randomized, double-blind, parallel group, controlled dose-finding and safety study of STR-324 in post-operative pain - Dose finding study of STR-324

ALAXIA SAS0 个研究点目标入组 118 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•1. Patient aged 18-75 years old, at screening;
•2. Having signed an informed consent prior to any study-related procedure;
•3. Patients planned to undergo a major laparoscopic abdominal or pelvic surgery;
•4. Surgery to be performed without local or regional anaesthesia nor
•infiltration;
•5. Body mass index (BMI) between 18 and 35 kg/m² inclusive at screening;
•6. Women of childbearing potential must agree to use at least one effective
•contraceptive method upon enrolment and for 1 cycle following the last dose of
•the investigational product.

•1. Patient contra-indicated for morphine administration;
•2. Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD,
•major anxiety, or depression). Subjects who take stable doses (same dose >30
•days) of antidepressants and/or anti-anxiety drugs may be included;
•3. Women who are pregnant or breastfeeding;
•4. History of alcohol, opiate or other drug abuse. For alcohol abuse, this
•means problematic use or >21 standardized alcohol units per week;
•5. Evidence of any active or chronic disease or condition that could interfere
•with, or for which the treatment might interfere with the conduct of the study,
•or that would pose an unacceptable risk to the subject in the opinion of the
•investigator (according to medical history, physical examination, vital signs
•(systolic and diastolic blood pressure, pulse rate), 12-lead electrocardiogram
•(ECG)). Minor deviations of values from the normal range may be accepted, if
•judged by the Investigator to have no clinical relevance;
•6. Clinically significant abnormalities, as judged by the investigator, in
•laboratory test results (including hepatic and renal panels, complete blood
•count, chemistry panel);
•7. Participation in an investigational drug or device study within 1 month
•prior to dosing.

发起方