Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
NCT ID: NCT02762929
Last Updated: 2023-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
430 participants
INTERVENTIONAL
2016-05-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HTX-011A: 200 mg
HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.
HTX-011A
HTX-011A (bupivacaine/meloxicam), via injection.
HTX-011B: 30 mg
HTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection.
HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
HTX-011B : 60 mg
HTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation.
HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
HTX-011B: 120 mg
HTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation.
HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
HTX-011B: 200 mg
HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection.
HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
Bupivacaine HCI
Bupivacaine HCI, 50 mg via injection.
Bupivacaine HCl
Bupivacaine HCI, via injection.
Saline Placebo
Saline placebo via injection.
Saline Placebo
Saline placebo via injection.
HTX-002, 60 mg
HTX- 002, 60 mg via injection.
HTX-002
HTX-002, via injection.
HTX-002, 120 mg
HTX-002, 120 mg via injection.
HTX-002
HTX-002, via injection.
HTX-002, 200 mg
HTX-002, 200 mg via injection.
HTX-002
HTX-002, via injection.
HTX-009
HTX-009, 3.6 mg via injection.
HTX-009
HTX-009, via injection.
Interventions
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HTX-011A
HTX-011A (bupivacaine/meloxicam), via injection.
Saline Placebo
Saline placebo via injection.
HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
HTX-002
HTX-002, via injection.
Bupivacaine HCl
Bupivacaine HCI, via injection.
HTX-009
HTX-009, via injection.
Eligibility Criteria
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Inclusion Criteria
2. Female subjects are eligible only if all of the following apply:
1. Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery)
2. Not lactating
3. Not planning to become pregnant while participating in the study
4. Be surgically sterile; or be at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or be practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study
3. Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication
4. Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
5. Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
6. Have the ability and be willing to comply with the study procedures.
7. Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form
Exclusion Criteria
2. Have a contraindication or be allergic to any medication to be used during the trial period
3. Have clinically significant cardiac abnormalities that, in the opinion of the investigator, would pose a health risk to the subject
4. Have American Society of Anesthesiologists (ASA) Physical Status classification system category ≥4
5. Have clinically significant renal or hepatic abnormalities: for example, AST or ALT \> 3x ULN, creatinine \> 2x ULN
6. Have another pre-existing painful condition that may confound pain assessments
7. Have another surgery planned within 30 days of procedure
8. Have a known or suspected history of alcohol or drug abuse, or a positive drug screen
9. Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of scheduled surgery for this study
10. Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
11. Subjects who are receiving oxygen therapy at the time of screening
12. Have participated in a clinical trial within 30 days of planned surgery
18 Years
ALL
No
Sponsors
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Heron Therapeutics
INDUSTRY
Responsible Party
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Locations
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Anaheim, California, United States
Bakersfield, California, United States
Pasadena, Maryland, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
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References
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Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg Anesth Pain Med. 2019 Dec 16:rapm-2019-100714. doi: 10.1136/rapm-2019-100714. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HTX-011-C2016-208
Identifier Type: -
Identifier Source: org_study_id
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