Post-surgical PainPhase 2NCT02807428
Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
A Phase 2 study testing AYX1 Injection 660 mg/6 mL in people with Post-surgical Pain, run by Adynxx, Inc. at 9 sites in United States.
Trial summary
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Post-surgical Pain
- What is being tested?
- AYX1 Injection 660 mg/6 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 9 sitesUnited States
- Study dates
- 20 Feb 2017to 19 Dec 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary unilateral TKA with spinal anesthesia for painful osteoarthritis without congenital knee pathology
- American Society of Anesthesiologists Physical Status Classification System ≤ 3
- Medically stable as determined by the Investigator based on pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings
- Body Mass Index of 18-45 kg/m2
- Stable medical regimen for at least 1 week before randomization
- Able to read and understand study instructions in English, and willing and able to comply with all study procedures
Who cannot join
- More than 2 other current focal areas of pain, any pain areas greater in intensity than the target knee, or any other active chronic pain conditions that would compromise operative knee pain evaluation
- Inflammatory arthridities (e.g., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis), with the exception of clinically stable/non-active gout that does not affect the knee and does not interfere with walking
- Surgery in either knee within 3 months prior to randomization, or surgery in either knee greater than 3 months prior to randomization with residual symptoms that would interfere with post-TKA study assessments; use of cryoneurolysis (including Iovera) on the current operative knee region within the 6 months prior to randomization and/or at any time through the duration of the study
- Planned use of general anesthesia or potent inhalational agents, peripheral nerve block (e.g., femoral nerve block), neuroaxial (intrathecal or epidural) opioids, preoperative extended release/long acting opioids, or any use of ketamine preoperatively and/or at any time through the duration of the study
- Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
- Use of gabapentin or pregabalin within 1 week prior to randomization or planned use post-operatively through Day 28
Show all 15Show fewer
- Use of systemic corticosteroids (IV or oral) within 3 months prior to randomization through Day 28; planned use of intra-articular steroid injections in the operative knee from the time of randomization through Day 28
- Current neurologic disorder, which could confound the assessment of pain (e.g., Parkinson's, Multiple Sclerosis)
- Untreated or inadequately treated (in the opinion of the Investigator) active depression
- Mini Mental State Exam score < 24 at screening
- History of alcohol-related complications within 1 year of randomization including, but not limited to, alcoholic withdrawal seizures, hallucinations, delirium tremens or detoxification treatment
- Known or suspected history of illicit drug use within 1 year before randomization, or current or planned use of marijuana (including medical approved use) within 1 month before randomization and/or through the duration of the study
- Any confirmed malignancy within the past year, with the exception of basal cell carcinoma or uncomplicated or stable skin cancers documented to not require further or immediate treatment
- Women who are pregnant or nursing
- Previous participation in any study involving AYX1 Injection
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Alabama Orthopedic Center
Birmingham, Alabama, 35209
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
CORE Orthopaedic Medical Center
Encinitas, California, 92024
Antria, Inc.
Indiana, Pennsylvania, 15701
Mississippi Sports Medicine
Jackson, Mississippi, 39202
Pensacola Research Consultants
Pensacola, Florida, 32503
Arizona Research Center
Phoenix, Arizona, 85023
Shoals Medical Trials
Sheffield, Alabama, 35660
Phoenix Clinical Research
Tamarac, Florida, 33321
About this study
Official title: A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of AYX1 Injection in Patients Undergoing Unilateral Total Knee Arthroplasty
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty.
Read the detailed description
This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of AYX1 Injection administered intrathecally before surgery in patients undergoing primary unilateral total knee arthroplasty (TKA). Subjects will be randomized on the day of surgery to receive either intrathecal AYX1 Injection or intrathecal placebo just prior to surgery. Study assessments will be conducted during the inpatient period through 48 hours; follow-up visits will be performed through Study Day 90.
- Conditions
- Post-surgical Pain
- Being tested
- AYX1 Injection 660 mg/6 mL, Placebo Injection 6 mL
- Keywords
- post-surgical pain, total knee arthroplasty, total knee replacement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYX1 Injection 660 mg/6 mLDrug
Also called Brivoligide 660 mg/6 mL
6 mL solution for intrathecal injection with 660 mg of AYX1 (Brivoligide)
Placebo Injection 6 mLDrug
6 mL solution for intrathecal injection; vehicle formulation designed to mimic AYX1 Injection (with no active drug)
| Study group | Role | What they receive |
|---|---|---|
| AYX1 Injection 660 mg/6 mL | Experimental | Single Intrathecal (spinal) administration of AYX1 Injection (660 mg in 6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery. Receives: Drug: AYX1 Injection 660 mg/6 mL |
| Placebo Injection 6 mL | Placebo comparator | Single Intrathecal (spinal) administration of Placebo Injection (6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery Receives: Drug: Placebo Injection 6 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain with walking during the 15 meter walk test Day 7 to Day 28
Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 15 meter walk test during the outpatient period from Day 7 to Day 28
Measured: 7-28 days post-surgery
Secondary outcomes (3)
Percentage of subjects with NRS pain score ≥ 4 during the 15 meter walk at Day 90
Percentage of subjects with the Numerical Rating Scale (NRS) pain score ≥ 4 during the 15 meter walk at Day 90
Measured: at 90 days post-surgery
Mean pain rating (NRS) at rest Day 7 to Day 28
Mean pain rating with the Numerical Rating Scale (NRS) at rest Day 7 to Day 28
Measured: 7-28 days post-surgery
Total use of postoperative opioid medications (morphine equivalents) post-discharge to Day 90
Total use of postoperative opioid medications (morphine equivalents) post-discharge to Day 90
Measured: post-hospital discharge through 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start20 Feb 2017
- Primary completion23 Oct 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgical 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adynxx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald C Manning, MD, PhD, Study director, Adynxx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807428
- Sponsor's protocol ID
- ADYX-004
- Status last verified
- Oct 2018
- First submitted
- 17 Jun 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of AYX1 Injection in Patients Undergoing Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02807428
- Acronym / sponsor ID
- ADYX-004
- Conditions
- Post-surgical Pain
- Keywords
- post-surgical pain, total knee arthroplasty, total knee replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Adynxx, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- 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.
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty.
Detailed description
This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of AYX1 Injection administered intrathecally before surgery in patients undergoing primary unilateral total knee arthroplasty (TKA). Subjects will be randomized on the day of surgery to receive either intrathecal AYX1 Injection or intrathecal placebo just prior to surgery. Study assessments will be conducted during the inpatient period through 48 hours; follow-up visits will be performed through Study Day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AYX1 Injection 660 mg/6 mL | Experimental | Drug: AYX1 Injection 660 mg/6 mLSingle Intrathecal (spinal) administration of AYX1 Injection (660 mg in 6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery. |
| Placebo Injection 6 mL | Placebo comparator | Drug: Placebo Injection 6 mLSingle Intrathecal (spinal) administration of Placebo Injection (6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled to undergo primary unilateral TKA with spinal anesthesia for painful osteoarthritis without congenital knee pathology
- American Society of Anesthesiologists Physical Status Classification System ≤ 3
- Medically stable as determined by the Investigator based on pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings
- Body Mass Index of 18-45 kg/m2
- Stable medical regimen for at least 1 week before randomization
Key exclusion criteria (15 listed)
- More than 2 other current focal areas of pain, any pain areas greater in intensity than the target knee, or any other active chronic pain conditions that would compromise operative knee pain evaluation
- Inflammatory arthridities (e.g., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis), with the exception of clinically stable/non-active gout that does not affect the knee and does not interfere with walking
- Surgery in either knee within 3 months prior to randomization, or surgery in either knee greater than 3 months prior to randomization with residual symptoms that would interfere with post-TKA study assessments; use of cryoneurolysis (including Iovera) on the current operative knee region within the 6 months prior to randomization and/or at any time through the duration of the study
- Planned use of general anesthesia or potent inhalational agents, peripheral nerve block (e.g., femoral nerve block), neuroaxial (intrathecal or epidural) opioids, preoperative extended release/long acting opioids, or any use of ketamine preoperatively and/or at any time through the duration of the study
- Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
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 |
|---|---|---|
| AYX1 Injection 660 mg/6 mLAlso: Brivoligide 660 mg/6 mL6 mL solution for intrathecal injection with 660 mg of AYX1 (Brivoligide) | Drug | AYX1 Injection 660 mg/6 mL |
| Placebo Injection 6 mL6 mL solution for intrathecal injection; vehicle formulation designed to mimic AYX1 Injection (with no active drug) | Drug | Placebo Injection 6 mL |
Primary outcome
Mean pain with walking during the 15 meter walk test Day 7 to Day 28
Time frame: 7-28 days post-surgery
Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 15 meter walk test during the outpatient period from Day 7 to Day 28
3 secondary outcomes
Percentage of subjects with NRS pain score ≥ 4 during the 15 meter walk at Day 90
Time frame: at 90 days post-surgery
Mean pain rating (NRS) at rest Day 7 to Day 28
Time frame: 7-28 days post-surgery
Total use of postoperative opioid medications (morphine equivalents) post-discharge to Day 90
Time frame: post-hospital discharge through 90 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- 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.
Donald C Manning, MD, PhD study director
Adynxx, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AYX1 Injection 660 mg/6 mL in people with Post-surgical Pain, run by Adynxx, Inc. at 9 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 6 inclusion and 15 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 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean pain with walking during the 15 meter walk test Day 7 to Day 28 (time frame: 7-28 days post-surgery). 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 17 Oct 2018.