Postsurgical Pain Clinical Trial
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
Verified date | July 2015 |
Source | Adynxx, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Adynxx, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of subjects achieving 90 degrees of knee flexion | Percentage of subjects achieving 90 degrees of active knee flexion in the operative knee at Discharge through Day 42 | Hospital discharge to Day 42 | No |
Primary | 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) | 0-48 hours after surgery | No |
Primary | 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 | Hospital Discharge to Day 28 | No |
Secondary | 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 | 0-48 hours after surgery | No |
Secondary | 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 | Hospital discharge to Day 28 | No |
Secondary | Total use of opioid medications (morphine equivalents) during hospital stay | 0-48 hours after surgery | No | |
Secondary | Total use of opioid medications (morphine equivalents) post-discharge to Day 28 | Hospital Discharge to Day 28 | No |
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