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A Phase 2, Two-Part Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy (HTX-011)

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. Identifier: NCT02471898
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : February 14, 2017
Information provided by (Responsible Party):
Heron Therapeutics

Brief Summary:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

Condition or disease Intervention/treatment Phase
Analgesia Drug: HTX-011 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Four-Part Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Study Start Date : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HTX-011
Evaluate the analgesic efficacy of HTX-011
Drug: HTX-011
Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. SPI0-24 [ Time Frame: 24 hours ]
    Summed Pain Intensity Scores over the first 24 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Voluntarily provide written informed consent.
  2. Male or female between 18 and 65 years of age, inclusive.
  3. Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
  4. Be American Society of Anesthesiology (ASA) physical Class 1 or 2.
  5. 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 and for 30 days from completion of the study.
  6. Male patients 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.
  7. Have a body mass index ≤ 35 kg/m2.
  8. Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
  9. Be able to understand and communicate in English.

Exclusion Criteria:

  1. Have a known allergy to Bupivacaine/Meloxicam or any HTX-011/placebo excipient or to any peri- or postoperative medications used in this study including oxycodone lidocaine, propofol, fentanyl, and midazolam.
  2. Have a clinically significant abnormal clinical laboratory test value according to the judgment of the investigator.
  3. Have history of or positive test results for HIV or hepatitis B or C at screening.
  4. 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.
  5. Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
  6. Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of postoperative pain.
  7. Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
  8. Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with HTX-011-19.
  9. Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator.
  10. Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse.
  11. 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; however, the urine drug screen at prior to surgery must be negative) at screening, and/or prior to surgery.
  12. Unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half-lives of the specific prior medication (or, if half-life is not known, within 48 hours) before dosing with study medication.
  13. Have utilized corticosteroids, either systemically, inhaled either intranasally or orally, or by intra-articular injection, within 14 days prior to the study surgical procedure.
  14. Have received any investigational product within 30 days before dosing with study medication.
  15. Have previously received HTX-011-19 in clinical trials or had bunionectomy in the last 3 months.
  16. Experiences a clinically significant event during surgery prior to the administration of the investigational product (e.g., excessive bleeding, hemodynamic instability) that would render the subject medically unstable, complicate their postsurgical course, or significantly increase the risk of study drug administration as per the judgment of the investigator.

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 identifier (NCT number): NCT02471898

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United States, California
Pasadena, California, United States, 91105
Sponsors and Collaborators
Heron Therapeutics
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Responsible Party: Heron Therapeutics Identifier: NCT02471898    
Other Study ID Numbers: HTX-011-C2015-201
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms