Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-20 @ 7:25 PM
Study NCT ID:
NCT02081703
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'dispFirstSubmitDate': '2015-07-14', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2014-03-05', 'dispFirstSubmitQcDate': '2015-07-14', 'studyFirstSubmitQcDate': '2014-03-05', 'dispFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of subjects achieving 90 degrees of knee flexion', 'timeFrame': 'Hospital discharge to Day 42', 'description': 'Percentage of subjects achieving 90 degrees of active knee flexion in the operative knee at Discharge through Day 42'}], 'primaryOutcomes': [{'measure': 'Pain with walking during 5 meter walk test', 'timeFrame': '0-48 hours after surgery', 'description': 'Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 5 meter walk test during the inpatient stay (0-48 hours)'}, {'measure': 'Pain with walking during 15 meter walk test', 'timeFrame': 'Hospital Discharge to Day 28', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Pain with 45 degrees of knee flexion', 'timeFrame': '0-48 hours after surgery', 'description': 'Mean pain rating on the Numerical Rating Scale (NRS) for 45 degrees passive knee flexion during the inpatient stay'}, {'measure': 'Pain with 90 degrees of knee flexion', 'timeFrame': 'Hospital discharge to Day 28', 'description': 'Mean pain rating on the Numerical Rating Scale (NRS) for 90 degrees passive knee flexion during the outpatient period to Day 28'}, {'measure': 'Total use of opioid medications (morphine equivalents) during hospital stay', 'timeFrame': '0-48 hours after surgery'}, {'measure': 'Total use of opioid medications (morphine equivalents) post-discharge to Day 28', 'timeFrame': 'Hospital Discharge to Day 28'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postsurgical pain', 'Total knee arthroplasty', 'Total knee replacement'], 'conditions': ['Postsurgical Pain']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled to undergo primary unilateral TKA for painful osteoarthritis without congenital knee pathology\n* American Society of Anesthesiologists Physical Status Classification System ≤ 3\n* 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\n* Body Mass Index of 18-40 kg/m2\n* Stable medical regimen for at least 1 month before randomization\n* Able to read and understand study instructions in English, and willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n* 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\n* 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\n* 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\n* 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\n* 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\n* Use of more than 20 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization\n* 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\n* Daily use of benzodiazepines in the 3 months prior to randomization (unless used for sleep and dosage will be consistent after surgery)\n* 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\n* 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)\n* Current neurologic disorder, which could confound the assessment of pain (e.g., Parkinson's, Multiple Sclerosis)\n* Current active depression symptoms\n* Has had a change in dose or regimen of SSRIs or SNRIs for depression within 1 month of randomization\n* Mini Mental State Exam score \\< 24 at Screening\n* 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.\n* 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\n* 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\n* 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\n* Women who are pregnant or nursing\n* Previous participation in any study involving AYX1 Injection"}, 'identificationModule': {'nctId': 'NCT02081703', 'briefTitle': 'Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adynxx, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ADYX-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AYX1 Injection 660 mg / 6 mL', 'description': 'Single Intrathecal (spinal) administration of AYX1 Injection (660 mg in 6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery', 'interventionNames': ['Drug: AYX1 Injection 660 mg / 6 mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Injection 6 mL', 'description': 'Single Intrathecal (spinal) administration of Placebo Injection (6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery', 'interventionNames': ['Drug: Placebo Injection 6 mL']}, {'type': 'EXPERIMENTAL', 'label': 'AYX1 Injection 1100 mg / 10 mL', 'description': 'Single Intrathecal (spinal) administration of AYX1 Injection (1100 mg in 10 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery', 'interventionNames': ['Drug: AYX1 Injection 1100 mg / 10 mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Injection 10 mL', 'description': 'Single Intrathecal (spinal) administration of Placebo Injection (10 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery', 'interventionNames': ['Drug: Placebo Injection 10 mL']}], 'interventions': [{'name': 'AYX1 Injection 660 mg / 6 mL', 'type': 'DRUG', 'description': '6 mL solution for intrathecal injection with 660 mg of AYX1', 'armGroupLabels': ['AYX1 Injection 660 mg / 6 mL']}, {'name': 'AYX1 Injection 1100 mg / 10 mL', 'type': 'DRUG', 'description': '10 mL solution for intrathecal injection with 1100 mg of AYX1', 'armGroupLabels': ['AYX1 Injection 1100 mg / 10 mL']}, {'name': 'Placebo Injection 6 mL', 'type': 'DRUG', 'description': '6 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)', 'armGroupLabels': ['Placebo Injection 6 mL']}, {'name': 'Placebo Injection 10 mL', 'type': 'DRUG', 'description': '10 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)', 'armGroupLabels': ['Placebo Injection 10 mL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Donald C Manning, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adynxx, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adynxx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}