AnalgesiaPhase 2HTX-011NCT02471898
HTX-011 for Post-bunionectomy Analgesia
A Phase 2 study testing HTX-011 in people with Analgesia, run by Heron Therapeutics at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- HTX-011
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Sep 2015
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provide written informed consent.
- Male or female between 18 and 65 years of age, inclusive.
- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
- Be American Society of Anesthesiology (ASA) physical Class 1 or 2.
- 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);
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- 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.
- 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.
- Have a body mass index ≤ 35 kg/m2.
- Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
- Be able to understand and communicate in English.
Who cannot join
- 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.
- Have a clinically significant abnormal clinical laboratory test value according to the judgment of the investigator.
- Have history of or positive test results for HIV or hepatitis B or C at screening.
- 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.
- Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
- Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of postoperative pain.
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- 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.
- 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.
- Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator.
- 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.
- 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.
- 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.
- Have utilized corticosteroids, either systemically, inhaled either intranasally or orally, or by intra-articular injection, within 14 days prior to the study surgical procedure.
- Have received any investigational product within 30 days before dosing with study medication.
- Have previously received HTX-011-19 in clinical trials or had bunionectomy in the last 3 months.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Analgesia
- Being tested
- HTX-011, Placebo
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTX-011Drug
Also called ZYNRELEF
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| HTX-011 | Experimental | Evaluate the analgesic efficacy of HTX-011 Receives: Drug: HTX-011 |
| Placebo | Placebo comparator | Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPI0-24
Summed Pain Intensity (SPI) Scores over the first 24 hours, which was the sum of the pain intensity scores at the scheduled 1 hour assessment, the assessments scheduled for every 2 hours between Hours 2 and 14, and the assessments scheduled at Hours 18 and 24; with the assessments at Hours 1 and 2 each weighted by 1, the assessments between Hours 4 and 14 each weighted by 2, the assessment at Hour 18 weighted by 4, and the assessment at Hour 24 weighted by 6. Pain was assessed using an 11-point scale, where 0 equaled no pain and 10 equaled the worst pain imaginable. Thus, the minimum and maximum possible SPI0-24 scores were 0 and 240, respectively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471898
- Sponsor's protocol ID
- HTX-011-C2015-201
- Acronym
- HTX-011
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2015
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No