BunionPhase 3STRIDENCT03954639
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
A Phase 3 study testing EXPAREL 13.3Mg/mL Suspension for Injection and Bupivacaine Hydrochloride in people with Bunion and Metatarsophalangeal Fusion, run by Pacira Pharmaceuticals, Inc.
Trial summary
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bunion, Metatarsophalangeal Fusion, Midfoot Fusion
- What is being tested?
- EXPAREL 13.3Mg/mL Suspension for Injection and Bupivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2020to Sep 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult male or female volunteers ages 18 or older
- American Society of Anesthesiologists (ASA) physical status 1, 2 or 3.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
- Body Mass Index ≥18 and ≤40 kg/m2
Who cannot join
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
- Documented history of long-term diabetes, renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
- Previous participation in EXPAREL study
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- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
- Currently pregnant, nursing, or planning to become pregnant during the study
- Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
- Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
- Inadequate sensory function on the foot (monofilament test)
- Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)
- In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:
- Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course
About this study
Official title: A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine vs. Bupivacaine Only Administered as Combined Sciatic (in Popliteal Fossa) and Adductor Canal Nerve Block for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
- Conditions
- Bunion, Metatarsophalangeal Fusion, Midfoot Fusion, Hindfoot Fusion, Total Ankle Arthroplasty, Forefoot Surgery
- Being tested
- EXPAREL 13.3Mg/mL Suspension for Injection, Bupivacaine Hydrochloride
- Medical subject headings
- Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPAREL 13.3Mg/mL Suspension for InjectionDrug
Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
Bupivacaine HydrochlorideDrug
Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Group 1 | Experimental | Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL.
EXPAREL will be mixed with Bupivacaine
Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety. Receives: Drug: EXPAREL 13.3Mg/mL Suspension for Injection |
| Cohort 1, Group 2 | Active comparator | Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine.
Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety. Receives: Drug: Bupivacaine Hydrochloride |
| Cohort 2, Group 1 | Experimental | Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL.
EXPAREL will be mixed with Bupivacaine
Subjects enrolled in Cohort 2 will provide measures for efficacy and safety. Receives: Drug: EXPAREL 13.3Mg/mL Suspension for Injection |
| Cohort 2, Group 2 | Active comparator | Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine.
Subjects enrolled in Cohort 2 will provide measures for efficacy and safety. Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of analgesic effect
Area under the Curve of the NRS Pain intensity scores from 0 hours to 96 hours post-surgery.
Measured: 0 hours to 96 hours
Secondary outcomes (1)
Total Postsurgical Opioid Consumption
Total Postsurgical opioid consumption from 0 hours to 96 hours post-surgery
Measured: 0 hours to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start15 Jun 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Sponsor Decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BunionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954639
- Sponsor's protocol ID
- 402-C-332
- Acronym
- STRIDE
- Status last verified
- May 2020
- First submitted
- 15 May 2019
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine vs. Bupivacaine Only Administered as Combined Sciatic (in Popliteal Fossa) and Adductor Canal Nerve Block for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
- ClinicalTrials.gov ID
- NCT03954639
- Acronym / sponsor ID
- STRIDE / 402-C-332
- Conditions
- Bunion, Metatarsophalangeal Fusion, Midfoot Fusion, Hindfoot Fusion, Total Ankle Arthroplasty, Forefoot Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 17 May 2019 (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 is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Group 1 | Experimental | Drug: EXPAREL 13.3Mg/mL Suspension for InjectionSubjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL. EXPAREL will be mixed with Bupivacaine Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety. |
| Cohort 1, Group 2 | Active comparator | Drug: Bupivacaine HydrochlorideSubjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine. Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety. |
| Cohort 2, Group 1 | Experimental | Drug: EXPAREL 13.3Mg/mL Suspension for InjectionSubjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL. EXPAREL will be mixed with Bupivacaine Subjects enrolled in Cohort 2 will provide measures for efficacy and safety. |
| Cohort 2, Group 2 | Active comparator | Drug: Bupivacaine HydrochlorideSubjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine. Subjects enrolled in Cohort 2 will provide measures for efficacy and safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult male or female volunteers ages 18 or older
- American Society of Anesthesiologists (ASA) physical status 1, 2 or 3.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
- Body Mass Index ≥18 and ≤40 kg/m2
Key exclusion criteria (14 listed)
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
- Documented history of long-term diabetes, renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
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 |
|---|---|---|
| EXPAREL 13.3Mg/mL Suspension for InjectionCombined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose) | Drug | Cohort 1, Group 1, Cohort 2, Group 1 |
| Bupivacaine HydrochlorideCombined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL | Drug | Cohort 1, Group 2, Cohort 2, Group 2 |
Primary outcome
Magnitude of analgesic effect
Time frame: 0 hours to 96 hours
Area under the Curve of the NRS Pain intensity scores from 0 hours to 96 hours post-surgery.
1 secondary outcome
Total Postsurgical Opioid Consumption
Time frame: 0 hours to 96 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EXPAREL 13.3Mg/mL Suspension for Injection and Bupivacaine Hydrochloride in people with Bunion and Metatarsophalangeal Fusion, run by Pacira Pharmaceuticals, Inc.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of analgesic effect (time frame: 0 hours to 96 hours). 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 Aug 2020.