Postsurgical PainPhase 2NCT02081703
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
A Phase 2 study testing AYX1 Injection 660 mg / 6 mL and AYX1 Injection 1100 mg / 10 mL in people with Postsurgical Pain, run by Adynxx, Inc. at 2 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 at two dose/volume levels. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Postsurgical Pain
- What is being tested?
- AYX1 Injection 660 mg / 6 mL and AYX1 Injection 1100 mg / 10 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Jun 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary unilateral TKA 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/neurological examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings
- Body Mass Index of 18-40 kg/m2
- Stable medical regimen for at least 1 month 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, none greater in intensity than the target knee and no 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
- Operative arthroscopy in the surgical knee in the last 4 months (except for meniscal repair which will be no shorter than 6 months before randomization) or in the contralateral knee in the last 2 months (or 3 months for meniscal repair), or other prior surgery in either knee in the last 12 months, except for diagnostic arthroscopy
- Planned use of any of the following for TKA: general anesthesia using potent inhalational agents, peripheral nerve block (i.e., femoral nerve block), neuroaxial (intrathecal or epidural) opioids postoperatively, or knee capsule injections
- Received aspirin or any nonsteroidal anti-inflammatory drug (NSAID) prior to randomization within the washout period required by the surgical team for surgery with spinal anesthetic, or planned use of NSAIDS post-operatively through Day 28
- Use of more than 20 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
Show all 20Show fewer
- Use of adjuvant analgesics for chronic pain control (e.g., gabapentin, pregabalin) within 2 weeks prior to randomization or planned use post-operatively through Day 28
- Daily use of benzodiazepines in the 3 months prior to randomization (unless used for sleep and dosage will be consistent after surgery)
- Use of systemic corticosteroids (does not include inhaled steroids) within 3 months or intra-articular steroid injections within 1 month prior to randomization, or planned use of either post-operatively through Day 28
- Treatment with immunosuppressives, antipsychotics, anticholinergics, or anticonvulsants within 1 month of randomization, with the exception of aspirin for cardiac prophylaxis (as long as discontinued within 1 week of randomization)
- Current neurologic disorder, which could confound the assessment of pain (e.g., Parkinson's, Multiple Sclerosis)
- Current active depression symptoms
- Has had a change in dose or regimen of SSRIs or SNRIs for depression within 1 month of randomization
- Mini Mental State Exam score < 24 at Screening
- Severe pulmonary disease; if symptomatic sleep apnea is currently treated with continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP), use must be continued postoperatively at least during the inpatient period. Patients with sleep apnea associated with a history of postoperative delirium are excluded.
- Current evidence of alcohol abuse or 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 abuse within 1 year before randomization, current or planned use of medical marijuana, or history of opioid dependence within 2 years before randomization
- Any 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
2 sites in 1 country.
United States2 sites
Study site
Phoenix, Arizona
Study site
Sheffield, Alabama
About this study
Official title: A Phase 2 Study to Evaluate the Safety & Efficacy of Two Dose/Volume Levels 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 at two dose/volume levels.
- Conditions
- Postsurgical Pain
- Being tested
- AYX1 Injection 660 mg / 6 mL, AYX1 Injection 1100 mg / 10 mL, Placebo Injection 6 mL, Placebo Injection 10 mL
- Keywords
- Postsurgical 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
6 mL solution for intrathecal injection with 660 mg of AYX1
AYX1 Injection 1100 mg / 10 mLDrug
10 mL solution for intrathecal injection with 1100 mg of AYX1
Placebo Injection 6 mLDrug
6 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
Placebo Injection 10 mLDrug
10 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 |
| AYX1 Injection 1100 mg / 10 mL | Experimental | Single Intrathecal (spinal) administration of AYX1 Injection (1100 mg in 10 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery Receives: Drug: AYX1 Injection 1100 mg / 10 mL |
| Placebo Injection 10 mL | Placebo comparator | Single Intrathecal (spinal) administration of Placebo Injection (10 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery Receives: Drug: Placebo Injection 10 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with walking during 5 meter walk test
Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 5 meter walk test during the inpatient stay (0-48 hours)
Measured: 0-48 hours after surgery
Pain with walking during 15 meter walk test
Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 15 meter walk test during the outpatient period up to Day 28
Measured: Hospital Discharge to Day 28
Secondary outcomes (4)
Pain with 45 degrees of knee flexion
Mean pain rating on the Numerical Rating Scale (NRS) for 45 degrees passive knee flexion during the inpatient stay
Measured: 0-48 hours after surgery
Pain with 90 degrees of knee flexion
Mean pain rating on the Numerical Rating Scale (NRS) for 90 degrees passive knee flexion during the outpatient period to Day 28
Measured: Hospital discharge to Day 28
Total use of opioid medications (morphine equivalents) during hospital stay
Measured: 0-48 hours after surgery
Total use of opioid medications (morphine equivalents) post-discharge to Day 28
Measured: Hospital Discharge to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical 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
- 120 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
- NCT02081703
- Sponsor's protocol ID
- ADYX-003
- Status last verified
- Jul 2015
- First submitted
- 5 Mar 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety & Efficacy of Two Dose/Volume Levels of a Single Intrathecal Preoperative Administration of AYX1 Injection in Patients Undergoing Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02081703
- Acronym / sponsor ID
- ADYX-003
- Conditions
- Postsurgical Pain
- Keywords
- Postsurgical pain, Total knee arthroplasty, Total knee replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Adynxx, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Mar 2014 (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 at two dose/volume levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| 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 |
| AYX1 Injection 1100 mg / 10 mL | Experimental | Drug: AYX1 Injection 1100 mg / 10 mLSingle Intrathecal (spinal) administration of AYX1 Injection (1100 mg in 10 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery |
| Placebo Injection 10 mL | Placebo comparator | Drug: Placebo Injection 10 mLSingle Intrathecal (spinal) administration of Placebo Injection (10 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled to undergo primary unilateral TKA 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/neurological examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings
- Body Mass Index of 18-40 kg/m2
- Stable medical regimen for at least 1 month before randomization
Key exclusion criteria (20 listed)
- More than 2 other current focal areas of pain, none greater in intensity than the target knee and no 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
- Operative arthroscopy in the surgical knee in the last 4 months (except for meniscal repair which will be no shorter than 6 months before randomization) or in the contralateral knee in the last 2 months (or 3 months for meniscal repair), or other prior surgery in either knee in the last 12 months, except for diagnostic arthroscopy
- Planned use of any of the following for TKA: general anesthesia using potent inhalational agents, peripheral nerve block (i.e., femoral nerve block), neuroaxial (intrathecal or epidural) opioids postoperatively, or knee capsule injections
- Received aspirin or any nonsteroidal anti-inflammatory drug (NSAID) prior to randomization within the washout period required by the surgical team for surgery with spinal anesthetic, or planned use of NSAIDS post-operatively through Day 28
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 mL6 mL solution for intrathecal injection with 660 mg of AYX1 | Drug | AYX1 Injection 660 mg / 6 mL |
| AYX1 Injection 1100 mg / 10 mL10 mL solution for intrathecal injection with 1100 mg of AYX1 | Drug | AYX1 Injection 1100 mg / 10 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 |
| Placebo Injection 10 mL10 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug) | Drug | Placebo Injection 10 mL |
Primary outcome
Pain with walking during 5 meter walk test
Time frame: 0-48 hours after surgery
Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 5 meter walk test during the inpatient stay (0-48 hours)
Pain with walking during 15 meter walk test
Time frame: Hospital Discharge to Day 28
Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 15 meter walk test during the outpatient period up to Day 28
4 secondary outcomes
Pain with 45 degrees of knee flexion
Time frame: 0-48 hours after surgery
Pain with 90 degrees of knee flexion
Time frame: Hospital discharge to Day 28
Total use of opioid medications (morphine equivalents) during hospital stay
Time frame: 0-48 hours after surgery
Total use of opioid medications (morphine equivalents) post-discharge to Day 28
Time frame: Hospital Discharge to Day 28
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 4 Aug 2015.
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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.
2 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 and AYX1 Injection 1100 mg / 10 mL in people with Postsurgical Pain, run by Adynxx, Inc. at 2 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 20 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Pain with walking during 5 meter walk test (time frame: 0-48 hours after surgery). 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 4 Aug 2015.