Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
15 oktober 2018 uppdaterad av: Adynxx, Inc.
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
210
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35209
- Alabama Orthopedic Center
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Sheffield, Alabama, Förenta staterna, 35660
- Shoals Medical Trials
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85023
- Arizona Research Center
-
-
California
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Encinitas, California, Förenta staterna, 92024
- CORE Orthopaedic Medical Center
-
-
Florida
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Pensacola, Florida, Förenta staterna, 32503
- Pensacola Research Consultants
-
Tamarac, Florida, Förenta staterna, 33321
- Phoenix Clinical Research
-
-
Mississippi
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Jackson, Mississippi, Förenta staterna, 39202
- Mississippi Sports Medicine
-
-
Ohio
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Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University Wexner Medical Center
-
-
Pennsylvania
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Indiana, Pennsylvania, Förenta staterna, 15701
- Antria, Inc.
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo Injection 6 mL
Single Intrathecal (spinal) administration of Placebo Injection (6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery
|
6 mL solution for intrathecal injection; vehicle formulation designed to mimic AYX1 Injection (with no active drug)
|
|
Experimentell: AYX1 Injection 660 mg/6 mL
Single Intrathecal (spinal) administration of AYX1 Injection (660 mg in 6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery.
|
6 mL solution for intrathecal injection with 660 mg of AYX1 (Brivoligide)
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean pain with walking during the 15 meter walk test Day 7 to Day 28
Tidsram: 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
|
7-28 days post-surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of subjects with NRS pain score ≥ 4 during the 15 meter walk at Day 90
Tidsram: at 90 days post-surgery
|
Percentage of subjects with the Numerical Rating Scale (NRS) pain score ≥ 4 during the 15 meter walk at Day 90
|
at 90 days post-surgery
|
|
Mean pain rating (NRS) at rest Day 7 to Day 28
Tidsram: 7-28 days post-surgery
|
Mean pain rating with the Numerical Rating Scale (NRS) at rest Day 7 to Day 28
|
7-28 days post-surgery
|
|
Total use of postoperative opioid medications (morphine equivalents) post-discharge to Day 90
Tidsram: post-hospital discharge through 90 days post-surgery
|
Total use of postoperative opioid medications (morphine equivalents) post-discharge to Day 90
|
post-hospital discharge through 90 days post-surgery
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Donald C Manning, MD, PhD, Adynxx, Inc.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 februari 2017
Primärt slutförande (Faktisk)
23 oktober 2017
Avslutad studie (Faktisk)
19 december 2017
Studieregistreringsdatum
Först inskickad
17 juni 2016
Först inskickad som uppfyllde QC-kriterierna
17 juni 2016
Första postat (Uppskatta)
21 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ADYX-004
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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