Postsurgical Pain Clinical Trial
Official title:
Study to Evaluate the Safety & Efficacy of a Single Intrathecal Pre-Operative Administration of AYX1 Injection at Two Dose Levels Compared to Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty (TKA)
Verified date | January 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 proof of concept study are to evaluate the safety and preventive analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty.
Status | Completed |
Enrollment | 102 |
Est. completion date | November 2013 |
Est. primary completion date | October 2013 |
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 - 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 lab tests, and 12-lead ECG findings - Body mass index of 18-40 kg/m2 - Stable medical regimen for = 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 (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis, gout) - Operative arthroscopy in the surgical knee in the last 6 months, 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 endotracheal anesthesia (GETA), peripheral nerve block (i.e., femoral nerve block), neuroaxial (intrathecal or epidural) opioids postoperatively, or knee capsule injections - Received aspirin within 1 week of randomization, or any nonsteroidal anti-inflammatory drug (NSAID) within 5 half-lives prior to randomization, 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 (i.e., gabapentin, pregabalin) during the month 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-op through Day 28 - Treatment with antibiotics or antivirals (EXCEPTION: topical treatments), immunosuppressives, antipsychotics, anticholinergics, or anticonvulsants within 1 month of randomization, with the exception of prescribed pre-surgical prophylactic antibiotics, and aspirin for cardiac prophylaxis (as long as discontinued within 1 week of randomization - Current neurologic disorder, which could confound the assessment of pain (i.e., 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 - Current history of insulin dependent diabetes mellitus, or autoimmune conditions - Severe chronic obstructive or restrictive pulmonary disease, current diagnosis of obstructive sleep apnea documented by a sleep laboratory study, or current home use of continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP) - Current evidence of alcohol abuse or history of alcohol-related complications within 1 year of randomization - 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 |
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 | Brief Pain Inventory functional interference scores at Days 7, 14, 21, 28, and 42 | 7 to 42 days after surgery | 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 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 outpatient period up to Day 28 | From 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 | From 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 active knee flexion | 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 active knee flexion | From 7 to 28 days after surgery | No |
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