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Dose Finding Study of STR-324

A

Alaxia

Status and phase

Unknown
Phase 2

Conditions

Pain, Acute

Treatments

Drug: STR-324
Drug: Morphine
Drug: Morphine HCl

Study type

Interventional

Funder types

Industry

Identifiers

NCT04582786
STR-324-CL-072
2019-003019-80 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

118 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Selection criteria:

  1. Patient aged ≥18 to <65 years old, at screening;
  2. Having signed an informed consent prior to any study-related procedure;
  3. Patients planned to undergo a major laparoscopic abdominal or pelvic surgery;
  4. Surgery to be performed without local or regional anaesthesia nor infiltration;
  5. Body mass index (BMI) between 18 and 30 kg/m² inclusive at screening, and with a minimum weight of 50 kg;
  6. 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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

118 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Annie-Claude Benichou; Pascale Vermare

Data sourced from clinicaltrials.gov

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