Pain, AcutePhase 2NCT04582786
Dose Finding Study of STR-324
A Phase 2 study testing Morphine, Morphine HCl and STR-324 in people with Pain, Acute, run by Alaxia SAS at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Morphine, Morphine HCl and STR-324
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2020to Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The criteria for definitive enrolment must be checked in the Post-Anaesthesia Care Unit (PACU) at the inclusion visit:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, H05-22
Monique Van Velzen, +31 71 526 2301, M.van_Velzen@lumc.nl
About this study
Official title: A Proof of Concept Randomized, Double-blind, Parallel Group, Controlled Dose-finding and Safety Study of STR-324 in Post-operative Pain
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.
Read the 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
- Being tested
- Morphine, Morphine HCl, STR-324
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Repeated bolus according to pain score
Morphine HClDrug
Infusion of morphine HCl solution for intravenous administration
STR-324Drug
Infusion of solution for intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | Standard treatment (morphine) administered according to usual practice Receives: Drug: Morphine |
| Test group: Infusion with bolus | Experimental | STR-324 or morphine HCl infusion started with a initial bolus Receives: Drug: Morphine HCl; Drug: STR-324 |
| Test group: Infusion without bolus | Experimental | STR-324 or morphine HCl infusion started without a initial bolus Receives: Drug: Morphine HCl; Drug: STR-324 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Any untoward medical occurrence in a patient or a clinical investigation subject, which does not necessarily have a causal relationship with the study treatment.
Measured: AEs collected directly after surgery until at least 30 days after the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Dec 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaxia SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582786
- Sponsor's protocol ID
- STR-324-CL-072
- Other IDs
- 2019-003019-80, 2019
- Status last verified
- Jul 2021
- First submitted
- 25 Sep 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Randomized, Double-blind, Parallel Group, Controlled Dose-finding and Safety Study of STR-324 in Post-operative Pain
- ClinicalTrials.gov ID
- NCT04582786
- Acronym / sponsor ID
- STR-324-CL-072
- Conditions
- Pain, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Alaxia SASIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Drug: MorphineStandard treatment (morphine) administered according to usual practice |
| Test group: Infusion with bolus | Experimental | Drug: Morphine HCl, Drug: STR-324STR-324 or morphine HCl infusion started with a initial bolus |
| Test group: Infusion without bolus | Experimental | Drug: Morphine HCl, Drug: STR-324STR-324 or morphine HCl infusion started without a initial bolus |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The criteria for definitive enrolment must be checked in the Post-Anaesthesia Care Unit (PACU) at the inclusion visit:
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineRepeated bolus according to pain score | Drug | Standard group |
| Morphine HClInfusion of morphine HCl solution for intravenous administration | Drug | Test group: Infusion with bolus, Test group: Infusion without bolus |
| STR-324Infusion of solution for intravenous administration | Drug | Test group: Infusion with bolus, Test group: Infusion without bolus |
Primary outcome
Qualitative Change of Pain Intensity
Time frame: 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.
Quantitative Change of Pain Intensity
Time frame: 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.
1 secondary outcome
Adverse events collection
Time frame: AEs collected directly after surgery until at least 30 days after the day of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Morphine, Morphine HCl and STR-324 in people with Pain, Acute, run by Alaxia SAS at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie-Claude Benichou (+33 4 78 42 95 26, clinical@bioalaxia.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Change of Pain Intensity (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.