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Dose Finding Study of STR-324

NCT04582786 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-07-13

No results posted yet for this study

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

Interventions

DRUG

Morphine

Repeated bolus according to pain score

DRUG

Morphine HCl

Infusion of morphine HCl solution for intravenous administration

DRUG

STR-324

Infusion of solution for intravenous administration

Sponsors & Collaborators

  • Alaxia SAS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04582786 on ClinicalTrials.gov