Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
NCT ID: NCT03974932
Last Updated: 2023-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2019-06-05
2021-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
HTX-011 + MMA
HTX-011
Dual-acting local anesthetic. Dose 1.
Ibuprofen
NSAID.
Acetaminophen
Analgesic.
Celecoxib
NSAID.
Luer Lock Applicator
Applicator for instillation.
Cohort 2
HTX-011 + MMA
HTX-011
Dual-acting local anesthetic. Dose 1.
Ibuprofen
NSAID.
Acetaminophen
Analgesic.
Celecoxib
NSAID.
Luer Lock Applicator
Applicator for instillation.
Cohort 3
HTX-011 + MMA
Ibuprofen
NSAID.
Acetaminophen
Analgesic.
Celecoxib
NSAID.
+/- Bupivacaine HCl
Local anesthetic.
Luer Lock Applicator
Applicator for instillation.
HTX-011
Dual-acting local anesthetic. Dose 2.
Cohort 4
HTX-011 + MMA
HTX-011
Dual-acting local anesthetic. Dose 1.
Ibuprofen
NSAID.
Acetaminophen
Analgesic.
Luer Lock Applicator
Applicator for instillation.
Interventions
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HTX-011
Dual-acting local anesthetic. Dose 1.
Ibuprofen
NSAID.
Acetaminophen
Analgesic.
Celecoxib
NSAID.
+/- Bupivacaine HCl
Local anesthetic.
Luer Lock Applicator
Applicator for instillation.
HTX-011
Dual-acting local anesthetic. Dose 2.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Heron Therapeutics
INDUSTRY
Responsible Party
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Locations
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Helen Keller Hospital
Sheffield, Alabama, United States
Phoenix Clinical Research, LLC
Tamarac, Florida, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States
First Surgical Hospital
Bellaire, Texas, United States
Plano Surgical Hospital
Plano, Texas, United States
Endeavor Clinical Trials, LLC.
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HTX-011-306
Identifier Type: -
Identifier Source: org_study_id
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