Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery

NCT02689258 | Completed Phase 2 Results

• 1 other identifier: HTX-011-C2015-203
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 8

Brief Summary

A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Summed Pain Intensity Scores Collected Over 24 Hours

  The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\*PI4+2\*PI6+2\*PI8+2\*PI10+2\*PI12+2\*PI14+4\*PI18+6\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).

  24 hours

Study Arms (12)

Part A, Cohort A: HTX-011A

EXPERIMENTAL

HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection

Drug: HTX-011A

Parts A and B, Cohort B: Saline Placebo

PLACEBO COMPARATOR

Saline placebo via injection

Drug: Placebo

Part A, Cohort C: HTX-011B

EXPERIMENTAL

HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection

Drug: HTX-011B

Part A, Cohort D: HTX-011B

EXPERIMENTAL

HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection

Drug: HTX-011B

Part A, Cohort E: HTX-011B

EXPERIMENTAL

HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination

Drug: HTX-011B

Part A, Cohort F: HTX-011B

EXPERIMENTAL

HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection

Drug: HTX-011B

Part B, Cohort A: HTX-002

EXPERIMENTAL

HTX-002, 400 mg via combination

Drug: HTX-002

Part C, Cohort A: HTX-011B

EXPERIMENTAL

HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation

Drug: HTX-011B

Part C, Cohort B: HTX-011B

EXPERIMENTAL

HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination

Drug: HTX-011B

Part C, Cohort C: HTX-011B

EXPERIMENTAL

HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination

Drug: HTX-011B

Part C, Cohort D: Bupivacaine HCI

ACTIVE COMPARATOR

Bupivacaine HCl, 100 mg via injection

Drug: Bupivicaine HCl

Part C, Cohort E: Saline Placebo

PLACEBO COMPARATOR

Saline placebo via injection

Drug: Placebo

Interventions

HTX-011B DRUG

HTX- 011B (bupivacaine/meloxicam) via injection

Part A, Cohort C: HTX-011B; Part A, Cohort D: HTX-011B; Part A, Cohort E: HTX-011B; Part A, Cohort F: HTX-011B; Part C, Cohort A: HTX-011B; Part C, Cohort B: HTX-011B; Part C, Cohort C: HTX-011B

Placebo DRUG

Saline placebo via injection

Part C, Cohort E: Saline Placebo; Parts A and B, Cohort B: Saline Placebo

HTX-011A DRUG

HTX- 011A (bupivacaine/meloxicam) via injection

Part A, Cohort A: HTX-011A

HTX-002 DRUG

HTX-002 via combination

Part B, Cohort A: HTX-002

Bupivicaine HCl DRUG

Bupivacaine HCl via injection

Part C, Cohort D: Bupivacaine HCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be considered eligible to participate in the study:
• Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol
• Be American Society of Anesthesiology (ASA) physical Class I or II
• Subjects 18 years of age or older
• Have clinical laboratory values that are within normal limits (WNL); subjects with AST/ALT \< 3 x ULN, and/or creatinine \< 2 x ULN are acceptable.
• Have a body mass index ≤ 30 kg/m2
• Female subjects are eligible only if all of the following apply:
• Not pregnant (female subject of child bearing potential must have a negative serum pregnancy tests at screening and negative urine pregnancy test before surgery)
• Not lactating
• Not planning to become pregnant during the study
• Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is 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
• 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
• Does NOT have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
• Must be able to understand study procedures and be willing to comply and give informed consent for the conduct of all study procedures, using an IRB approved consent

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from participating in the study:
• Have a contraindication or be allergic to any medication to be used during the trial period
• Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of post-operative pain
• Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants
• 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 surgery
• Previous abdominal surgery, as determined by the investigator, that would preclude participation in the study
• Subjects that require liposuction as part of the abdominoplasty procedure in Part A of the protocol
• Subjects that are to have ancillary procedures performed during the abdominoplasty surgery that are unrelated to the abdominal area (breast reduction, breast augmentation, etc.)
• Subjects unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the scheduled abdominoplasty procedure and before dosing with investigational product
• Subjects taking the following medications; anticonvulsants, sedatives (including benzodiazepines) corticosteroids (by any means of administration), nonsteroidal anti-inflammatory drugs (NSAIDS) within 24 hours of study drug dosing, morphine, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin-norepinephrine reuptake inhibitors (SNRIs). Gabapentin and pregabalin are not permitted
• Have a known or suspected history of alcohol or drug abuse
• Have positive results on the alcohol breath test indicative of alcohol abuse or urine drug screen indicative of illicit drug use (unless results can be explained by a current prescription or acceptable over-the-counter medication at screening as determined by the investigator). The urine drug screen prior to surgery must be negative
• Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator
• Have received any investigational product within 30 days before start of study
• Have previously received HTX-011 in clinical trials

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (8)

Unknown Facility

Phoenix, Arizona, 85023, United States

Location

Unknown Facility

Pasadena, California, 91105, United States

Location

Unknown Facility

Pasadena, Maryland, 21122, United States

Location

Unknown Facility

Bellaire, Texas, 77401, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

Houston, Texas, 77019, United States

Location

Unknown Facility

Houston, Texas, 77027, United States

Location

Unknown Facility

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Tricia Mulford
• Organization: Heron Therapeutics, Inc.

tmulford@herontx.com

760-622-3709

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 23, 2016
• Study Start: February 23, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 2, 2026
• Results First Posted: October 4, 2023

Record last verified: 2026-02

Locations

US (8)