Covid 19 Research using Clinical Trials (Home Page)
Report for D010149: Pain, Postoperative NIH
(Synonyms: Pain, P, Pain, Pos, Pain, Post, Pain, Postope, Pain, Postoper, Pain, Postoperat, Pain, Postoperativ, Pain, Postoperative)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3312 | ioveraº sham Wiki | 0.71 |
| drug2535 | ST-2427 Wiki | 0.71 |
| drug3311 | ioveraº Wiki | 0.71 |
| drug2122 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (0)
| Name (Synonyms) | Correlation |
|---|
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 A Multicenter, Double-blind, Randomized, Sham-controlled Study Assessing Opioid Utilization, Postoperative Pain and Function in Subjects Undergoing Total Knee Arthroplasty Treated With Presurgical Iovera®° or Sham Iovera®° Cryoneurolysis and Postsurgical Multimodal Pain Regimen
Primary objective: The primary objective of this study is to evaluate either a) the postsurgical total opioid consumption or b) postsurgical pain control after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA). A single primary objective, either a or b, will be declared by an unblinded Independent Review Committee (IRC) in an interim analysis after 30 randomized and treated subjects complete the Day 42 assessments. The primary objective not selected will be placed in the secondary objectives category. Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption (whichever is not chosen as the primary objective), opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral TKA
NCT04191031 Post-Operative Pain Management Device: ioveraº Device: ioveraº sham MeSH:Pain, Postoperative
Primary Outcomes
Measure: Total opioid consumption in oral morphine equivalent dose from TKA (Day 1) to Day 42 (6 weeks post-TKA) Time: Day 1 to Day 42Secondary Outcomes
Description: NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
Measure: The area under the curve (AUC) of the Numeric Rating Scale (NRS) "worst pain" intensity scores from TKA (Day 1) to Day 42 (6 weeks post-TKA) Time: Day 1 to Day 42Description: NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
Measure: Numeric Rating Scale (NRS) pain intensity scores "right now" at Day 15, 30, 42, and Day 90 Time: Day 15 to Day 90Description: NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
Measure: Numeric Rating Scale (NRS) pain intensity scores "average pain" at Day 4 to Day 42 Time: Day 4 to Day 42Measure: Total opioid consumption in oral morphine equivalents from TKA-Day 15, TKA-Day 30, TKA-Day 42, and TKA-Day 90 Time: Day 1 to Day 90
2 A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427 IV Infusion in Healthy Subjects
This randomized, double-blind, placebo controlled, study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. The study will be conducted in 2 parts. In Part A of this study, subjects will be randomized to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. In Part B of this study, subjects will be randomized to receive up to 6 repeat doses of ST-2427 or placebo, administered twice-daily (BID) every 12 hours, in a Multiple Ascending Dose (MAD) design. In Part A and Part B, study drug (ST-2427 or placebo) will be administered intravenously (IV) over 1 hour. A total of 48 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.
NCT04475198 Acute, Post-operative Pain Drug: ST-2427 Drug: Placebo MeSH:Pain, Postoperative
Primary Outcomes
Description: For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.
Measure: Incidence and severity of treatment-emergent adverse events Time: Day 1 through Day 8Description: Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP], will be used to analyze for change from baseline.
Measure: Incidence and severity of adverse events assessed by blood pressure Time: Day 1 through Day 8Description: Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections, using concentration-QTc analysis, and on other ECG parameters (heart rate, PR and QRS interval and treatment emergent T and U-wave abnormalities).
Measure: Incidence and severity of adverse events assessed by ECG Time: Day 1 through Day 8Description: The Holter recordings will also be analyzed for the presence of arrhythmias and for derivation of heart rate variability (HRV).
Measure: Incidence and severity of adverse events assessed by Continous Holter Monitoring Time: Day 1 through Day 8Description: Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.
Measure: Incidence and severity of treatment-emergent events assessed by clinical laboratory assessments Time: Day 1 through Day 8Description: Body weight (kg) will be assessed for changes relative to baseline.
Measure: Incidence and severity of adverse events assessed by body weight Time: Day 1 through Day 8Secondary Outcomes
Description: PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.
Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Cmax Time: Day 1 through Day 5Description: PK modeling will be performed using compartmental methods. The elimination half-life of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.
Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Elimination half-life Time: Day 1 through Day 5Description: PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.
Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Area under the curve Time: Day 1 through Day 5Description: The ST-2427 concentrations in the urine will be measured in 4 hour increments by cohort for the SAD.
Measure: Pharmacokinetics of ST-2427 concentration in urine Time: Day 1 through Day 5