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

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: NCT03974932
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : March 9, 2021
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 Drug: Ibuprofen Drug: Acetaminophen Drug: Celecoxib Drug: +/- Bupivacaine HCl Device: Luer Lock Applicator Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Non-Randomized
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
Actual Primary Completion Date : December 7, 2020
Actual Study Completion Date : January 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Cohort 1
HTX-011 + MMA
Drug: HTX-011
Dual-acting local anesthetic. Dose 1.

Drug: Ibuprofen
NSAID.

Drug: Acetaminophen
Analgesic.

Drug: Celecoxib
NSAID.

Device: Luer Lock Applicator
Applicator for instillation.

Experimental: Cohort 2
HTX-011 + MMA
Drug: HTX-011
Dual-acting local anesthetic. Dose 1.

Drug: Ibuprofen
NSAID.

Drug: Acetaminophen
Analgesic.

Drug: Celecoxib
NSAID.

Device: Luer Lock Applicator
Applicator for instillation.

Experimental: Cohort 3
HTX-011 + MMA
Drug: Ibuprofen
NSAID.

Drug: Acetaminophen
Analgesic.

Drug: Celecoxib
NSAID.

Drug: +/- Bupivacaine HCl
Local anesthetic.

Device: Luer Lock Applicator
Applicator for instillation.

Drug: HTX-011
Dual-acting local anesthetic. Dose 2.

Experimental: Cohort 4
HTX-011 + MMA
Drug: HTX-011
Dual-acting local anesthetic. Dose 1.

Drug: Ibuprofen
NSAID.

Drug: Acetaminophen
Analgesic.

Device: Luer Lock Applicator
Applicator for instillation.




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 severe pain. [ 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)

  17. Maximum concentration (Cmax) [ Time Frame: 72 hours ]
  18. Time of occurrence of maximum concentration (Tmax) [ Time Frame: 72 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
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United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Florida
Phoenix Clinical Research, LLC
Tamarac, Florida, United States, 33321
United States, Ohio
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States, 45417
United States, Texas
First Surgical Hospital
Bellaire, Texas, United States, 77401
Plano Surgical Hospital
Plano, Texas, United States, 75093
Endeavor Clinical Trials, LLC.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Heron Therapeutics
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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT03974932    
Other Study ID Numbers: HTX-011-306
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Heron Therapeutics:
total knee arthroplasty
postoperative pain
multimodal analgesia
Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Celecoxib
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors