An efficacy and safety study of STR-324 in post-operative pai

Phase 1

• Conditions: ociception; MedDRA version: 20.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-003019-80-NL
• Lead Sponsor: Stragen France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-13
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Pre-inclusion criteria: evaluated at the screening
• Patient aged =18 to <65 years old, at screening;
• Signed informed consent prior to any study-related procedure;
• Patients planned to undergo a major abdominal or pelvic surgery,;
• Surgery to be performed without local or regional anaesthesia nor infiltration;
• Body mass index (BMI) between 18 and 30 kg/m² inclusive at screening, and with a minimum weight of 50 kg;
• 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.

Evaluated in the Post-Anaesthesia Care Unit (PACU)
• NRS-measured pain intensity ranging from 4 to 8 inclusive at baseline PACU measurement;
• With Sedation score = S1 (awake or intermittently sleepy) at the time of pain assessment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 116
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified