Nociception MedDRA version: 20.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Product Name: STR-324 concentrate solution for infusion 64mg/2mL
Product Code: STR-324
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: 5-Oxo-L-Prolyl-L-arginyl-L-phenyl
Sponsors
Stragen France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre-inclusion criteria: evaluated at the screening • Patient aged =18 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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 anxiolytics drugs can be enrolled; • Women who are pregnant or breastfeeding; • History of alcohol, opioid or other drug abuse; • Step 1 specific exclusion criterion: patient contra-indicated for morphine administration; • 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; • Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel); • Participation in an investigational drug or device study within 1 month prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this dose-finding study is to evaluate the analgesic effect of 4 doses of STR-324 (maximum 2-hours infusion) on postoperative pain, measured by change of pain intensity assessed on a Numerical Rating Scale (NRS) using an 11-point scale (0-10).;Secondary Objective: The secondary objective of the study is to evaluate the safety and tolerability of STR-324.;Primary end point(s): Change of Pain Intensity assessed by the Numerical Rating Scale (NRS) after initiation of the post-op analgesia and before switch to standard treatment. Two parameters will be assessed: 1- Qualitative: a decrease of 2 units minimum from baseline and/or achievement of a pain score = 3 is considered successful; responder = Yes 2- Quantitative: maximum value of the pain score difference versus baseline;Timepoint(s) of evaluation of this end point: 12 time points collected: - before initiation of the post-op analgesia: baseline value - after initiation of the post-op analgesia: 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 min (If re-titration is required/performed, additional 5-min interval timepoints shall be added) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - AUC of Pain Intensity assessed by the Numerical Rating Scale (NRS) (11-points scale) during infusion corrected from baseline - Time to achieve effect, and in particular maximum effect - Pain level at the end of each infusion level - Percent of responders in each group - Time to switch to standard pain management (test groups) - Morphine dose administered up to 2 hours - Total dose of STR-324 - Comparison of curve profiles. Safety: - Adverse events collection - Haematology, biochemistry including liver function tests - Vital signs: Electrocardiogram, blood pressure and heart rate, respiratory rate.;Timepoint(s) of evaluation of this end point: EFFICACY: 12 time points collected: - before initiation of the post-op analgesia: baseline value - after initiation of the post-op analgesia: 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 min (If re-titration is required/performed, additional 5-min interval timepoints shall be added) . SAFETY: - baseline value at screening visit - at end of assessment (end of dosing or follow-up visit) - continuous collection of adverse events at least 30 days after the patient has received the treatment | — |
Countries
Netherlands
Contacts
Public ContactChief Medical Officer
Stragen France
Outcome results
None listed