Dose Finding Study of STR-324

NCT04582786 | Unknown Phase 2

• 2 other identifiers: STR-324-CL-0722019-003019-80
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (2)

• Qualitative Change of Pain Intensity

  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.

  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.

• Quantitative Change of Pain Intensity

  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.

  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.

Secondary Outcomes (1)

• Adverse events collection

  AEs collected directly after surgery until at least 30 days after the day of surgery.

Study Arms (3)

Standard group

ACTIVE COMPARATOR

Standard treatment (morphine) administered according to usual practice

Drug: Morphine

Test group: Infusion with bolus

EXPERIMENTAL

STR-324 or morphine HCl infusion started with a initial bolus

Drug: Morphine HCl; Drug: STR-324

Test group: Infusion without bolus

EXPERIMENTAL

STR-324 or morphine HCl infusion started without a initial bolus

Drug: Morphine HCl; Drug: STR-324

Interventions

Morphine DRUG

Repeated bolus according to pain score

Standard group

Morphine HCl DRUG

Infusion of morphine HCl solution for intravenous administration

Test group: Infusion with bolus; Test group: Infusion without bolus

STR-324 DRUG

Infusion of solution for intravenous administration

Test group: Infusion with bolus; Test group: Infusion without bolus

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patient contra-indicated for morphine administration;
• 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;
• Women who are pregnant or breastfeeding;
• History of alcohol, opiate or other drug abuse.
• 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;
• Clinically significant abnormalities, as judged by the investigator, in laboratory test results;
• Participation in an investigational drug or device study within 1 month prior to dosing.

Sponsors & Collaborators

• Alaxia SAS: lead

Study Sites (1)

Leiden University Medical Center

Leiden, H05-22, Netherlands

RECRUITING

MeSH Terms

Conditions

Acute Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Annie-Claude Benichou

CONTACT

+33 4 78 42 95 26; clinical@bioalaxia.eu

Pascale Vermare

CONTACT

+33 4 37 53 26 60; clinical@bioalaxia.eu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Step 1 of the study is single blinded for participants only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 12, 2020
• Study Start: December 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)