Postoperative PainPhase 2/3NCT01683071
Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty
A Phase 2/3 study testing EXPAREL 67 mg, EXPAREL 133 mg and EXPAREL 266 mg in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 30 sites in United States.
Trial summary
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- EXPAREL 67 mg, EXPAREL 133 mg and EXPAREL 266 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 30 sitesUnited States
- Study dates
- Sep 2012to Dec 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female, >=18 years of age.
- Scheduled to undergo primary unilateral TKA under general or spinal anesthesia.
- American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3.
- Able to demonstrate motor function by performing a 20-meter walk, unassisted with the optional use of a 4-legged walker, and sensory function by exhibiting sensitivity to cold.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Who cannot join
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control.
- If of childbearing potential, must have a documented negative pregnancy test within 24 hours before surgery.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Use of any of the following medications within the times specified before surgery:
- long-acting opioid medication, NSAIDs, aspirin (except for low-dose aspirin used for cardioprotection) or acetaminophen within 3 days, or and any opioid medication within 24 hours.
- Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the surgical site administered study treatment, and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, prior contralateral TKA, concurrent foot surgery).
Show all 21Show fewer
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinepherine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®).
- Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
- Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 40 kg/m2.
- Contraindication to hydromorphone, oxycodone, or bupivacaine.
- 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 a liposome bupivacaine study.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Failure to pass the urine drug screen.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance.
- Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postsurgical course.
- Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures.
- Subjects who are planned to receive Entereg® (alvimopan).
- Subjects who will receive prophylactic antiemetics or planned postsurgical antiemetics given without regard to the subject's emesis needs.
- Use of dexmedetomidine HCl (Precedex®) within 3 days of surgery.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
ACHIEVE CLINICAL RESEARCH LLC 2017 Canyon Road Suite 41
Birmingham, Alabama, 35216
COOPER UNIVERSITY HOSPITAL 1 Cooper Plaza 202 Dorrance Building
Camden, New Jersey, 08103
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL Department Of Anesthesiology 101 Manning Drive N0021, Cb 7010
Chapel Hill, North Carolina, 27599
CLEVELAND CLINIC FAIRVIEW HOSPTIAL 1801 Lorain Avenue
Cleveland, Ohio, 44111
CLEVELAND CLINIC 9500 Euclid Ave P-77
Cleveland, Ohio, 44195
FLORIDA RESEARCH ASSOCIATES, LLC / FLORIDA ORTHOPAEDIC ASSOCIATES 740 W. Plymouth Ave
DeLand, Florida, 32720
UNIVERSITY OF TEXAS MEDICAL BRANCH Dept. Chairman, Orthopedic Surgery & Rehabilitation 2.316 Rebecca Sealy Hospital 301 University Blvd.
Galveston, Texas, 77551
PENN STATE MILTON S. HERSHEY MEDICAL CENTER H187,500 University Drive
Hershey, Pennsylvania, 17033
RESEARCH CONCEPTS,GP LLC 921 Gessner Rd. Anesthesia Dept., Classroom F
Houston, Texas, 77024
UNIVERSITY OF KANSAS HOSPITAL & MEDICAL CENTER Dept. Of Anesthesiology 3901 Rainbow Blvd. Ms 1034
Kansas City, Kansas, 66160
ALLIANCE RESEARCH CENTERS 24411 Health Center Drive Suite 350
Laguna Hills, California, 92653
JACKSON MEMORIAL HOSPITAL UNVERSITY OF MIAMI 1611 Nw. 12th Ave C300
Miami, Florida, 33136
HORIZON RESEARCH GROUP INC 3610 Springhill Memorial Dr. N
Mobile, Alabama, 36608
Veritas Research, LLC
Mobile, Alabama, 36660
NORTHERN WESTCHESTER HOSPTIAL Department Of Clinical Trials 400 East Main St.
Mount Kisco, New York, 10549
CHRISTUS ST. JOHN HOSPITAL 18300 St. John Dr., 2nd Floor, Surgery
Nassau Bay, Texas, 77058
ST. LUKE-ROOSEVELT HOSPITAL CENTER Dept. Of Anesthesiology 1111 Amsterdam Ave. Travis Bld. 7
New York, New York, 10025
INSALL-SCOTT-KELLY INSTITUTE 210 East 64th Street
New York, New York, 10065
UNIVERSITY OF MEDICINE AND DENSITRY OF NEW JERSEY/NEW JERSEY MEDICAL SCHOOL 185 South Orange Ave. Department of Anesthesiology - MSB E538
Newark, New Jersey, 07101
PENSACOLA RESEARCH CONSULTANTS,INC 5149 N.9th Avenue Suite 241
Pensacola, Florida, 32504
THOMAS JEFFERSON UNIVERSITY Dept. Of Anesthesiology 111 S. 11th Street Suite G 8490
Philadelphia, Pennsylvania, 19107
PHOENIX ORTHOPAEDIC SURGEONS 2525 W. Greenway Road Suite 114
Phoenix, Arizona, 85023
UPMC PRESBYTERIAN SHADYSIDE/ DEPT. OF ANESTHESIOLOGY POSNER PAIN CENTER 532 South Aiken Avenue Suite 407
Pittsburgh, Pennsylvania, 15232
ORTHOPADIC SURGERY Loma Linda University Health Care Dept. Pf Orthopaedic Surgery 250 East Caroline Street Suite A
San Bernardino, California, 92508
University of California, San Diego
San Diego, California, 92103
Ilfeld, Brian (Thornton) UNIVERSITY OF CALIFORNIA, SAN DIEGO 10610 Hunters Glen Drive
San Diego, California, 92130
SHOALS MEDICAL TRIALS INC. 1300 S Montgomery Ave
Sheffield, Alabama, 35660
SHERIDAN CLINICAL RESEARCH, INC. 1613 N. Harrison Parkway Building C Suite 200
Sunrise, Florida, 33323
PHOENIX CLINICAL RESEARCH,LLC 7171 N. University Drive Suite 100
Tamarac, Florida, 33321
BEAUMONT HEALTH SYSTEM 44201 Dequindre Road Suite Pob 120
Troy, Michigan, 48085
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be tested in Part 2.
Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the analgesic effect of single injection femoral nerve block of a single dose level of liposome bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).
Read the detailed description
This is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study in subjects undergoing primary unilateral total knee arthroplasty (TKA) under general or spinal anesthesia. Note: Bupivacaine cannot be used as the spinal anesthetic.
Part 1 During Part 1 of the study, approximately 100 subjects (25 per treatment arm) will be randomized to receive a single dose injection femoral nerve block with either one of three doses of liposome bupivacaine (67, 133, or 266 mg) or placebo in 20 mL under ultrasound guidance. Preservative-free normal saline will be added to the 67 mg and 133 mg doses of study drug to achieve a volume of 20 mL.
Part 2 In Part 2 of the study, approximately 180 subjects (randomized 1:1, resulting in approximately 90 liposome bupivacaine subjects and 90 placebo subjects) will receive a single dose injection femoral nerve block with the selected dose level of liposome bupivacaine (i.e., 67, 133, or 266 mg) or placebo in 20 mL under ultrasound guidance.
- Conditions
- Postoperative Pain
- Being tested
- Placebo, EXPAREL 67 mg, EXPAREL 133 mg, EXPAREL 266 mg
- Keywords
- Total knee arthroplasty, Analgesia, Pain management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Preservative-free normal saline.
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
EXPAREL 67 mgDrug
Also called Bupivacaine liposome injectable suspension 67 mg/5 mL
5 mL EXPAREL expanded with 15 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
EXPAREL 133 mgDrug
Also called Bupivacaine liposome injectable suspension 133 mg/10 mL
10 mL EXPAREL expanded with 10 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
EXPAREL 266 mgDrug
Also called Bupivacaine liposome injectable suspension 266 mg/20 mL
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| (Part 1) EXPAREL 67 mg | Experimental | 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Receives: Drug: EXPAREL 67 mg |
| (Part 1) EXPAREL 133 mg | Experimental | 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Receives: Drug: EXPAREL 133 mg |
| (Part 1) EXPAREL 266 mg | Experimental | 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively Receives: Drug: EXPAREL 266 mg |
| (Part 1) Placebo | Placebo comparator | 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Receives: Drug: Placebo |
| (Part 2) EXPAREL 266 mg | Experimental | 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively Receives: Drug: EXPAREL 266 mg |
| (Part 2) Placebo | Placebo comparator | 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours
AUC of NRS-R pain intensity scores through 72 hours. Pain intensity scores were measured on an 11-point NRS (0=no pain and 10=worst possible pain)
Measured: 0-72 hours
Secondary outcomes (2)
Total Postsurgical Opioid Consumption Through 72 Hours
Total postsurgical opioid consumption of opioid rescue pain medication (converted to IV morphine equivalents) through 72 hours
Measured: 0-72 hours
Time to First Opioid Rescue Through 72 Hours
Time to first opioid rescue medication consumed through 72 hours
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erol Onel, MD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683071
- Sponsor's protocol ID
- 402-C-323
- Status last verified
- Nov 2020
- First submitted
- 7 Sep 2012
- Last updated
- 9 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01683071
- Acronym / sponsor ID
- 402-C-323
- Conditions
- Postoperative Pain
- Keywords
- Total knee arthroplasty, Analgesia, Pain management
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Posted 9 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be tested in Part 2.
Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the analgesic effect of single injection femoral nerve block of a single dose level of liposome bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).
Detailed description
This is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study in subjects undergoing primary unilateral total knee arthroplasty (TKA) under general or spinal anesthesia. Note: Bupivacaine cannot be used as the spinal anesthetic.
Part 1 During Part 1 of the study, approximately 100 subjects (25 per treatment arm) will be randomized to receive a single dose injection femoral nerve block with either one of three doses of liposome bupivacaine (67, 133, or 266 mg) or placebo in 20 mL under ultrasound guidance. Preservative-free normal saline will be added to the 67 mg and 133 mg doses of study drug to achieve a volume of 20 mL.
Part 2 In Part 2 of the study, approximately 180 subjects (randomized 1:1, resulting in approximately 90 liposome bupivacaine subjects and 90 placebo subjects) will receive a single dose injection femoral nerve block with the selected dose level of liposome bupivacaine (i.e., 67, 133, or 266 mg) or placebo in 20 mL under ultrasound guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| (Part 1) EXPAREL 67 mg | Experimental | Drug: EXPAREL 67 mg5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively |
| (Part 1) EXPAREL 133 mg | Experimental | Drug: EXPAREL 133 mg10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively |
| (Part 1) EXPAREL 266 mg | Experimental | Drug: EXPAREL 266 mg20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively |
| (Part 1) Placebo | Placebo comparator | Drug: Placebo20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively |
| (Part 2) EXPAREL 266 mg | Experimental | Drug: EXPAREL 266 mg20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively |
| (Part 2) Placebo | Placebo comparator | Drug: Placebo20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, >=18 years of age.
- Scheduled to undergo primary unilateral TKA under general or spinal anesthesia.
- American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3.
- Able to demonstrate motor function by performing a 20-meter walk, unassisted with the optional use of a 4-legged walker, and sensory function by exhibiting sensitivity to cold.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Key exclusion criteria (21 listed)
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control.
- If of childbearing potential, must have a documented negative pregnancy test within 24 hours before surgery.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Use of any of the following medications within the times specified before surgery:
- long-acting opioid medication, NSAIDs, aspirin (except for low-dose aspirin used for cardioprotection) or acetaminophen within 3 days, or and any opioid medication within 24 hours.
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 |
|---|---|---|
| PlaceboAlso: Preservative-free normal saline.Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty | Drug | (Part 1) Placebo, (Part 2) Placebo |
| EXPAREL 67 mgAlso: Bupivacaine liposome injectable suspension 67 mg/5 mL5 mL EXPAREL expanded with 15 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty | Drug | (Part 1) EXPAREL 67 mg |
| EXPAREL 133 mgAlso: Bupivacaine liposome injectable suspension 133 mg/10 mL10 mL EXPAREL expanded with 10 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty | Drug | (Part 1) EXPAREL 133 mg |
| EXPAREL 266 mgAlso: Bupivacaine liposome injectable suspension 266 mg/20 mL20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty | Drug | (Part 1) EXPAREL 266 mg, (Part 2) EXPAREL 266 mg |
Primary outcome
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours
Time frame: 0-72 hours
AUC of NRS-R pain intensity scores through 72 hours. Pain intensity scores were measured on an 11-point NRS (0=no pain and 10=worst possible pain)
2 secondary outcomes
Total Postsurgical Opioid Consumption Through 72 Hours
Time frame: 0-72 hours
Time to First Opioid Rescue Through 72 Hours
Time frame: 0-72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Erol Onel, MD study director
Pacira Pharmaceuticals, Inc
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EXPAREL 67 mg, EXPAREL 133 mg and EXPAREL 266 mg in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 30 sites in United States.
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 5 inclusion and 21 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: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours (time frame: 0-72 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 9 Dec 2020.