Dose Finding Study of STR-324

Phase 2

• Conditions: Pain, Acute
• Interventions: Drug: Morphine HCl; Drug: Morphine; Drug: STR-324

• Registration Number: NCT04582786
• Lead Sponsor: Alaxia SAS

Brief Summary

This study aims to evaluate the analgesic effect and the safety of 4 doses of STR-324 administered as an infusion, with or without initial bolus, to patients suffering from post-operative pain.

The sensitivity of the pain model used in the trial will be evaluated with a standard group treated with morphine under the usual care conditions.

Detailed Description

The first step (single-blind standard group) aims to verify the sensitivity of the study pain model in the proposed surgery to confirm the validity of the surgery according to their pain and enrolment rate. 12 patients are planned to be enrolled.

The second step (dose-finding study) is a randomized, double-blind, parallel groups, controlled clinical trial involving a total of 106 patients divided into two groups in which patients will be randomized between STR-324 and morphine HCl:

* Group 1: Titration initiated with a bolus

* Group 2: Titration without initial bolus.

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-12
• Study Start: 2020-12-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-13
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

The criteria for definitive enrolment must be checked in the Post-Anaesthesia Care Unit (PACU) at the inclusion visit:

1. NRS-measured pain intensity ranging from 4 to 8 inclusive at baseline PACU measurement;
2. With a sedation score ≤ S1 (awake or intermittently sleepy) at the time of pain assessment.

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.
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. 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;
7. Participation in an investigational drug or device study within 1 month prior to dosing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group: Infusion without bolus	Morphine HCl	STR-324 or morphine HCl infusion started without a initial bolus
Test group: Infusion without bolus	STR-324	STR-324 or morphine HCl infusion started without a initial bolus
Test group: Infusion with bolus	Morphine HCl	STR-324 or morphine HCl infusion started with a initial bolus
Test group: Infusion with bolus	STR-324	STR-324 or morphine HCl infusion started with a initial bolus
Standard group	Morphine	Standard treatment (morphine) administered according to usual practice

Primary Outcome Measures

Name	Time	Method
Quantitative Change of Pain Intensity	On and/or after study drug, with fixed timepoints at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105 and 120 minutes. If re-titration is required/performed, additional 5-minutes interval timepoints shall be added.	Pain Intensity will be assessed by a Numerical Rating Scale (NRS) before and during analgesic infusion. Change of Pain Intensity assessed by the Numerical Rating Scale (NRS) after initiation of the post-op analgesia and before switch to standard treatment.; The following parameter will be assessed: - Quantitative: maximum value of the pain score difference versus baseline.
Qualitative Change of Pain Intensity	On and/or after study drug, with fixed timepoints at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105 and 120 minutes. If re-titration is required/performed, additional 5-minutes interval timepoints shall be added.	Pain Intensity will be assessed by a Numerical Rating Scale (NRS) before and during analgesic infusion. Change of Pain Intensity assessed by the Numerical Rating Scale (NRS) after initiation of the post-op analgesia and before switch to standard treatment.; The following parameter will be assessed: - Qualitative: a decrease of 2 units minimum from baseline and/or achievement of a pain score ≤ 3 is considered successful, responder=Yes.

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	AEs collected directly after surgery until at least 30 days after the day of surgery.	Any untoward medical occurrence in a patient or a clinical investigation subject, which does not necessarily have a causal relationship with the study treatment.

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands