Dose Finding Study of STR-324

NCT ID: NCT04582786

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-01-31

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standard group

Standard treatment (morphine) administered according to usual practice

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Repeated bolus according to pain score

Test group: Infusion with bolus

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

Group Type: EXPERIMENTAL

Morphine HCl

Intervention Type: DRUG

Infusion of morphine HCl solution for intravenous administration

STR-324

Intervention Type: DRUG

Infusion of solution for intravenous administration

Test group: Infusion without bolus

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

Group Type: EXPERIMENTAL

Morphine HCl

Intervention Type: DRUG

Infusion of morphine HCl solution for intravenous administration

STR-324

Intervention Type: DRUG

Infusion of solution for intravenous administration

Interventions

Morphine

Repeated bolus according to pain score

Intervention Type: DRUG

Morphine HCl

Infusion of morphine HCl solution for intravenous administration

Intervention Type: DRUG

STR-324

Infusion of solution for intravenous administration

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alaxia SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leiden University Medical Center

Leiden, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Annie-Claude Benichou

Role: CONTACT

clinical@bioalaxia.eu

+33 4 78 42 95 26

Pascale Vermare

Role: CONTACT

clinical@bioalaxia.eu

+33 4 37 53 26 60

Facility Contacts

Monique Van Velzen

Role: primary

M.van_Velzen@lumc.nl

+31 71 526 2301

Other Identifiers

2019-003019-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

STR-324-CL-072

Identifier Type: -

Identifier Source: org_study_id