- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01731730
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
14 januari 2015 uppdaterad av: Adynxx, Inc.
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)
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
102
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Sheffield, Alabama, Förenta staterna
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Arizona
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Phoenix, Arizona, Förenta staterna
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Florida
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Boynton Beach, Florida, Förenta staterna
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Pennsylvania
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Altoona, Pennsylvania, Förenta staterna
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Texas
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Houston, Texas, Förenta staterna
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Nassau Bay, Texas, Förenta staterna
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Odessa, Texas, Förenta staterna
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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 till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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 |
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Placebo-jämförare: Placebo (Vehicle) Injection
Single Intrathecal (spinal) administration of Placebo Injection just prior to intrathecal administration of spinal anesthetic for knee surgery
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3mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
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Experimentell: AYX1 Injection 110 mg
Single Intrathecal (spinal) administration of AYX1 Injection (110 mg) just prior to intrathecal administration of spinal anesthetic for knee surgery
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3mL solution for intrathecal injection with 110 mg of AYX1
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Experimentell: AYX1 Injection 330 mg
Single Intrathecal (spinal) administration of AYX1 Injection (330 mg) just prior to intrathecal administration of spinal anesthetic for knee surgery
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3mL solution for intrathecal injection with 330 mg of AYX1
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pain with walking during 5 meter walk test
Tidsram: 0-48 hours after surgery
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Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 5 meter walk test during inpatient stay 0-48 hours
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0-48 hours after surgery
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Pain with walking during 15 meter walk test
Tidsram: From hospital discharge to Day 28
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Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 15 meter walk test during outpatient period up to Day 28
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From hospital discharge to Day 28
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Total use of opioid medications (morphine equivalents) during hospital stay
Tidsram: 0-48 hours after surgery
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0-48 hours after surgery
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Total use of opioid medications (morphine equivalents) post-discharge to Day 28
Tidsram: From hospital discharge to Day 28
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From hospital discharge to Day 28
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Pain with 45 degrees of knee flexion
Tidsram: 0-48 hours after surgery
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Mean pain rating on the Numerical Rating Scale (NRS) for 45 degrees active knee flexion
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0-48 hours after surgery
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Pain with 90 degrees of knee flexion
Tidsram: From 7 to 28 days after surgery
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Mean pain rating on the Numerical Rating Scale (NRS) for 90 degrees active knee flexion
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From 7 to 28 days after surgery
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Andra resultatmått
Resultatmått |
Tidsram |
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Brief Pain Inventory functional interference scores at Days 7, 14, 21, 28, and 42
Tidsram: 7 to 42 days after surgery
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7 to 42 days after surgery
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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
1 januari 2013
Primärt slutförande (Faktisk)
1 oktober 2013
Avslutad studie (Faktisk)
1 november 2013
Studieregistreringsdatum
Först inskickad
19 november 2012
Först inskickad som uppfyllde QC-kriterierna
19 november 2012
Första postat (Uppskatta)
22 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 januari 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 januari 2015
Senast verifierad
1 januari 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ADYX-002
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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