NCT02504580

Brief Summary

A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for phase_2 postoperative-pain

Timeline
Completed

Started Jul 2015

Typical duration for phase_2 postoperative-pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

October 4, 2023

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

July 16, 2015

Results QC Date

June 14, 2021

Last Update Submit

February 10, 2026

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Mean Summed Pain Intensity (SPI) Score

    Subjects assessed pain intensity for their current pain with the 11-point (0 to 10) Numeric Rating Scale NRS where "0" equated to "no pain" and "10" equated to "the worst pain imaginable". Pain intensity was assessed at rest (NRS-R) after the subject had been supine for a minimum of 5 minutes and with activity (NRS-A) sitting up from a supine position. The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 was 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 (22)

Part A, Cohort A

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by injection.

Drug: HTX-011

Part A, Cohort B

EXPERIMENTAL

HTX-011(bupivacaine/meloxicam), 400 mg/12 mg by injection.

Drug: HTX-011

Part A, Cohort C

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by instillation.

Drug: HTX-011

Part A, Cohort D

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by instillation.

Drug: HTX-011

Part A, Cohort E

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by injection and instillation (combination).

Drug: HTX-011

Part A, Cohort F

PLACEBO COMPARATOR

Saline placebo by injection.

Drug: Placebo

Part B, Cohort A

EXPERIMENTAL

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

Drug: HTX-011A

Part B, Cohort B

EXPERIMENTAL

HTX-011A (bupivacaine/meloxicam) 400 mg12 mg by injection.

Drug: HTX-011A

Part B, Cohort C

EXPERIMENTAL

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

Drug: HTX-011B

Part B, Cohort D

EXPERIMENTAL

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

Drug: HTX-011B

Part B, Cohort E

PLACEBO COMPARATOR

Saline placebo by injection.

Drug: Placebo

Part C, Cohort A

EXPERIMENTAL

HTX-002, 200 mg by injection or instillation.

Drug: HTX-002

Part B, Cohort F

EXPERIMENTAL

HTX-002, 400 mg by injection or instillation.

Drug: HTX-002

Part C, Cohort B

EXPERIMENTAL

HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by instillation.

Drug: HTX-011B

Part B, Cohort G

EXPERIMENTAL

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

Drug: HTX-011B

Part C, Cohort C

PLACEBO COMPARATOR

Saline placebo by instillation.

Drug: Placebo

Part C, Cohort D

ACTIVE COMPARATOR

Bupivacaine HCI (Marcaine), 75 mg by injection.

Drug: Bupivacaine HCI (Marcaine)

Part D, Cohort A

EXPERIMENTAL

HTX-011B (bupivacaine/meloxicam), 400 mg/13 mg via a combination of injection and instillation.

Drug: HTX-011B

Part E, Cohort A

EXPERIMENTAL

HTX-009, 12 mg by injection and instillation (combination).

Drug: HTX-009

Part F, Cohort A

EXPERIMENTAL

HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg by instillation.

Drug: HTX-011B

Part F, Cohort B

EXPERIMENTAL

Bupivacaine HCI (Marcaine), 75 mg by injection.

Drug: Bupivacaine HCI (Marcaine)

Part F, Cohort C

PLACEBO COMPARATOR

Saline placebo by injection.

Drug: Placebo

Interventions

HTX-011DRUG

HTX-011 (bupivacaine/meloxicam) by injection.

Part A, Cohort APart A, Cohort BPart A, Cohort CPart A, Cohort DPart A, Cohort E
PlaceboDRUG

Saline placebo by injection.

Part A, Cohort FPart B, Cohort EPart C, Cohort CPart F, Cohort C
HTX-002DRUG

HTX-002, by injection or instillation (pooled).

Part B, Cohort FPart C, Cohort A
Bupivacaine HCI (Marcaine)DRUG

Bupivacaine HCI (Marcaine) by injection.

Part C, Cohort DPart F, Cohort B
HTX-011ADRUG

HTX-011A (bupivacaine/meloxicam) by injection.

Part B, Cohort APart B, Cohort B
HTX-011BDRUG

HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.

Part B, Cohort CPart B, Cohort DPart B, Cohort GPart C, Cohort BPart D, Cohort APart F, Cohort A
HTX-009DRUG

HTX-009 by injection and instillation (combination).

Part E, Cohort A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be male or female 18 years of age or older.
  • 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 test 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
  • Male:
  • o 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.
  • Plan to undergo a unilateral inguinal herniorrhaphy
  • Have the ability and be willing to comply with the study procedures
  • Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form.

You may not qualify if:

  • Unwilling to sign informed consent or not willing or able to complete all study procedures
  • Have a contraindication or be allergic to any medication to be used during the trial period
  • Have clinically significant cardiac abnormalities, that in the opinion of the investigator would pose a health risk to the subject should they participate in the trial
  • Have American Society of Anesthesiologists (ASA) Physical Status classification system category 4 or greater (Appendix E)
  • Have clinically significant renal or hepatic abnormalities (defined as an AST or ALT \> 3x ULN, creatinine \> 2x ULN)
  • Have another painful condition that may confound pain assessments
  • Have another surgery planned within 30 days of procedure, or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with large scrotal component that would be difficult to reduce surgically
  • Have a known or suspected history of alcohol or drug abuse, or a positive drug screen
  • 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
  • Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
  • Female subjects who are pregnant (positive pregnancy test at screening or on the day of surgery)
  • Subjects who are receiving oxygen therapy at the time of screening
  • Have participated in a clinical trial within 30 days of planned surgery
  • Have a body mass index (BMI) \> 39 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 22, 2015

Study Start

July 1, 2015

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(3)