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Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen

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ClinicalTrials.gov Identifier: NCT03974932
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Brief Summary:
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.

Condition or disease Intervention/treatment Phase
Analgesia Drug: HTX-011 Device: Luer lock applicator Drug: Ibuprofen Drug: Acetaminophen Drug: Celecoxib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Open-Label Study of HTX-011 as Part of a Scheduled Non-Opioid Multimodal Analgesic Regimen in Subjects Undergoing Total Knee Arthroplasty
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Treatment Group 1
HTX-011; celecoxib, ibuprofen and acetaminophen
Drug: HTX-011
400 mg

Device: Luer lock applicator
Applicator for instillation

Drug: Ibuprofen
600 mg Days 4-7

Drug: Acetaminophen
1 g Days 1-7

Drug: Celecoxib
200 mg Days 1-3




Primary Outcome Measures :
  1. Mean area under the curve (AUC) of the the visual analogue scale (VAS). [ Time Frame: 12 through 48 hours ]

Secondary Outcome Measures :
  1. Mean AUC of VAS scores. [ Time Frame: 72 hours ]
  2. Mean AUC of the NRS of pain intensity at rest (NRS-R). [ Time Frame: 72 hours ]
  3. Proportion of subjects with an NRS-R score ≥7. [ Time Frame: 10 timepoints through 72 hours, and Day 11 and Day 29 ]
  4. Mean total postoperative opioid consumption (in IV morphine milligram equivalents [MME]). [ Time Frame: 72 hours ]
  5. Proportion of subjects who are opioid-free. [ Time Frame: through 72 hours, and through Day 11 ]
  6. Proportion of subjects who are opioid-free through 72 hours who remain opioid-free through 72 hours who remain opioid-free. [ Time Frame: 72 hours through Day 11 ]
  7. Median time to first opioid rescue medication. [ Time Frame: 72 hours ]
  8. Proportion of subjects who do not receive an opioid prescription at discharge. [ Time Frame: 72 hours ]
  9. Proportion of subjects who do not receive an opioid prescription between discharge and the Day 11 visit. [ Time Frame: 72 hours through Day 11 ]
  10. Proportion of subjects achieving a score of "good" or better (>1) pain control based on Patient Global Assessment (PGA). [ Time Frame: 24 hours, 48 hours, 72 hours, Day 11 ]
  11. Median time to first ambulation postsurgery. [ Time Frame: 72 hours ]
  12. Proportion of subjects unable to participate in each rehabilitation session because of pain. [ Time Frame: 72 hours ]
  13. Proportion of subjects who first achieve an MPADSS score ≥9. [ Time Frame: 10 timepoints through 72 hours ]
  14. Proportion of subjects who are discharged home vs to a skilled nursing facility. [ Time Frame: 72 hours ]
  15. Mean overall benefit of analgesia score (OBAS). [ Time Frame: 24 hours, 48 hours, 72 hours, Day 11 ]
  16. Mean total TSQM-9 score [ Time Frame: 72 hours through Day 11 ]
    Treatment Satisfaction Questionnaire for Medication (9-question)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is scheduled to undergo primary unilateral TKA under spinal anesthesia.
  • Has not previously undergone TKA in either knee.
  • Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
  • Is able to walk at least 20 feet with 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 is at least 2 years post-menopausal; or is in a monogamous relationship with a partner who is surgically sterile; or using acceptable contraceptives.

Exclusion Criteria:

  • Has a planned concurrent surgical procedure.
  • Has other pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
  • Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
  • Using or expected to use Factor IX Complex or anti-inhibitor coagulant concentrates during the study.
  • 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 with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
  • 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 been administered any local anesthetic within 72 hours 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.
  • Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
  • 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.
  • 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.
  • Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
  • Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments.
  • Has acquired defective color vision or acute gastrointestinal ulcers, either of which could interfere with scheduled study medications.
  • 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 nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
  • Has undergone 3 or more surgeries within 12 months.
  • Has a body mass index (BMI) >39 kg/m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974932


Contacts
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Contact: Erol Onel, MD (858) 251-4420 HTX011-ct@herontx.com

Locations
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United States, Alabama
Helen Keller Hospital Recruiting
Sheffield, Alabama, United States, 35660
United States, Florida
Phoenix Clinical Research, LLC Recruiting
Tamarac, Florida, United States, 33321
University Hospital & Medical Center Recruiting
Tamarac, Florida, United States, 33321
United States, Ohio
Medical Center at Elizabeth Place Recruiting
Dayton, Ohio, United States, 45417
Midwest Clinical Research Center, LLC Recruiting
Dayton, Ohio, United States, 45417
United States, Texas
Plano Surgical Hospital Recruiting
Plano, Texas, United States, 75093
Sponsors and Collaborators
Heron Therapeutics

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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT03974932     History of Changes
Other Study ID Numbers: HTX-011-306
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Heron Therapeutics:
total knee arthroplasty
postoperative pain
multimodal analgesia

Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors