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Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015532
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE January 13, 2017
Actual Primary Completion Date April 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
Mean area under the curve (AUC) of the NRS-R pain intensity scores [ Time Frame: 48 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
Mean area under the curve (AUC) of the NRS-R pain intensity scores [ Time Frame: 24 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • Mean area under the curve (AUC) of the NRS-R pain intensity scores [ Time Frame: 72 hours ]
  • Mean total postoperative opioid consumption (in morphine equivalents) [ Time Frame: 72 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
Mean total postoperative opioid consumption (in morphine equivalents) [ Time Frame: 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
Official Title  ICMJE A Phase 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty
Brief Summary This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Analgesia
Intervention  ICMJE
  • Drug: HTX-011
  • Drug: Saline Placebo
  • Drug: Bupivicaine HCl
    Bupivacaine HCl without epinephrine
  • Drug: Ropivacaine
Study Arms  ICMJE
  • Experimental: Cohort 1 Group 1
    HTX-011 (200 mg)
    Intervention: Drug: HTX-011
  • Placebo Comparator: Cohort 1 Group 2
    Saline placebo
    Intervention: Drug: Saline Placebo
  • Active Comparator: Cohort 1 Group 3
    Bupivacaine HCl without epinephrine 0.25% (125 mg)
    Intervention: Drug: Bupivicaine HCl
  • Experimental: Cohort 2 Group 1
    HTX-011 (400 mg)
    Intervention: Drug: HTX-011
  • Experimental: Cohort 2 Group 2
    HTX-011 (400 mg) plus ropivacaine 0.5% (50 mg)
    Interventions:
    • Drug: HTX-011
    • Drug: Ropivacaine
  • Placebo Comparator: Cohort 2 Group 3
    Saline placebo
    Intervention: Drug: Saline Placebo
  • Active Comparator: Cohort 2 Group 4
    Bupivacaine HCl without epinephrine 0.25% (125 mg)
    Intervention: Drug: Bupivicaine HCl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2018)
285
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2017)
120
Actual Study Completion Date  ICMJE May 16, 2018
Actual Primary Completion Date April 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is scheduled to undergo primary unilateral TKA under general anesthesia.
  • Has not previously undergone TKA in either knee.
  • Has an American Society of Anesthesiologists Physical Status of I, II, or III.
  • Is able to demonstrate motor function by performing a timed 20-meter walk unassisted, but with the optional use of a 4-legged walker for balance.
  • Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

  • Has a planned concurrent surgical procedure (eg, bilateral TKA).
  • Has a pre-existing concurrent acute or chronic painful/restrictive physical condition that may require analgesic treatment in the postoperative period for pain.
  • Has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications.
  • Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
  • Has taken NSAIDs within 10 days prior to the scheduled surgery.
  • Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
  • Has been administered bupivacaine within 5 days prior to the scheduled surgery.
  • Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
  • Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
  • Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
  • Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.
  • Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
  • Has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature. Has any chronic condition or disease that would compromise neurological or vascular assessments.
  • Had a malignancy in the last year, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
  • Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
  • Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
  • Has undergone 3 or more surgeries within 12 months.
  • Has a body mass index (BMI) >38 kg/m2.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03015532
Other Study ID Numbers  ICMJE HTX-011-209
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heron Therapeutics
Study Sponsor  ICMJE Heron Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heron Therapeutics
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP