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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 118

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>8.1.1 Primary endpoint<br /><br>Pain Intensity will be assessed by a Numerical Rating Scale (NRS) before and<br /><br>during analgesic infusion.<br /><br>Change of Pain Intensity assessed by the Numerical Rating Scale (NRS) after<br /><br>initiation of the post-op analgesia and before switch to standard treatment.<br /><br><br /><br>Two parameters will be assessed:<br /><br>Qualitative: a decrease of 2 units minimum from baseline and/or achievement of<br /><br>a pain score <=3 is considered successful, responder=Yes.<br /><br>Quantitative: maximum value of the pain score difference versus baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>8.1.2.1 Efficacy secondary end points<br /><br>AUC of Pain Intensity assessed by the Numerical Rating Scale (NRS) (11-<br /><br>points scale) during infusion corrected from baseline<br /><br>Time to first achieve effect, and in particular maximum effect<br /><br>Pain level at the end of each infusion level<br /><br>Percent of responders in each group<br /><br>Time to switch to standard pain management<br /><br>Total dose of STR-324<br /><br>Total dose of morphine HCl (for Step 2 only) before the switch to standard of<br /><br>care<br /><br>Comparison of curve profiles<br /><br><br /><br>8.1.2.2 Safety end points<br /><br>Adverse event collection<br /><br>Haematology parameters<br /><br>Biochemistry including liver function tests parameters<br /><br>Vital signs: blood pressure and heart rate, respiratory rate<br /><br>ECG parameters</p><br>