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Phase 2B Upper Extremity Nerve Block Study

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: NCT03011333
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 5, 2017
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE January 14, 2017
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
Mean area under the curve (AUC) of the NRS-R pain intensity scores [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03011333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
Mean total postoperative opioid consumption (in morphine equivalents) [ Time Frame: 72 Hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2B Upper Extremity Nerve Block Study
Official Title  ICMJE A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty
Brief Summary This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.
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: Bupivacaine HCl without epinephrine
  • Drug: Saline Placebo
Study Arms  ICMJE
  • Experimental: Group 1
    HTX-011 60 mg
    Intervention: Drug: HTX-011
  • Experimental: Group 2
    HTX-011 120 mg
    Intervention: Drug: HTX-011
  • Experimental: Group 3
    HTX-011 240 mg
    Intervention: Drug: HTX-011
  • Experimental: Group 4
    HTX-011 400 mg
    Intervention: Drug: HTX-011
  • Active Comparator: Group 5
    Bupivacaine HCl 50 mg
    Intervention: Drug: Bupivacaine HCl without epinephrine
  • Placebo Comparator: Group 6
    Saline Placebo
    Intervention: Drug: Saline Placebo
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)
243
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2017)
72
Actual Study Completion Date  ICMJE March 19, 2018
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 cc, inclusive. Note: textured implants are not allowed.
  • Has an American Society of Anesthesiologists Physical Status of I, II, or III.
  • 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.
  • Has a planned reconstructive procedure status post breast cancer therapy.
  • Has a 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 medication.
  • 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 scheduled surgery.
  • 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 other than to treat an AE that occurs after signing the ICF or for pretreatment prior to a needle placement.
  • Has initiated treatment with any of the following medications within 1 month prior to study drug administration or is taking any of these medications to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 (COX-2) inhibitors. (Note: If a subject is taking one of these medications for a reason other than pain control, she must be on a stable scheduled dose [ie, not "as needed"] for at least 1 month prior to study drug administration.) Anxiolytics prior to surgery are permitted, if necessary.
  • Has a medical condition 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, Hepatitis C, or human immunodeficiency virus (HIV).
  • Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
  • Has any chronic neuromuscular deficit of either pectoral nerve function or arm/shoulder/truncal 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. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.
  • 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 in 12 months.
  • Has a body mass index (BMI) >35 kg/m2.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 NCT03011333
Other Study ID Numbers  ICMJE HTX-011-211
Has Data Monitoring Committee No
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