- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02504580
A 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
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
-
-
Texas
-
Houston, Texas, United States, 77004
-
Houston, Texas, United States, 77027
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A, Cohort A
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by injection.
|
HTX-011 (bupivacaine/meloxicam) by injection.
|
Experimental: Part A, Cohort B
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg by injection.
|
HTX-011 (bupivacaine/meloxicam) by injection.
|
Experimental: Part A, Cohort C
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by instillation.
|
HTX-011 (bupivacaine/meloxicam) by injection.
|
Experimental: Part A, Cohort D
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by instillation.
|
HTX-011 (bupivacaine/meloxicam) by injection.
|
Experimental: Part A, Cohort E
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by injection and instillation (combination).
|
HTX-011 (bupivacaine/meloxicam) by injection.
|
Placebo Comparator: Part A, Cohort F
Saline placebo by injection.
|
Saline placebo by injection.
|
Experimental: Part B, Cohort A
HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg by injection.
|
HTX-011A (bupivacaine/meloxicam) by injection.
|
Experimental: Part B, Cohort B
HTX-011A (bupivacaine/meloxicam) 400 mg12 mg by injection.
|
HTX-011A (bupivacaine/meloxicam) by injection.
|
Experimental: Part B, Cohort C
HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by injection.
|
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
|
Experimental: Part B, Cohort D
HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by injection.
|
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
|
Placebo Comparator: Part B, Cohort E
Saline placebo by injection.
|
Saline placebo by injection.
|
Experimental: Part C, Cohort A
HTX-002, 200 mg by injection or instillation.
|
HTX-002, by injection or instillation (pooled).
|
Experimental: Part B, Cohort F
HTX-002, 400 mg by injection or instillation.
|
HTX-002, by injection or instillation (pooled).
|
Experimental: Part C, Cohort B
HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by instillation.
|
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
|
Experimental: Part B, Cohort G
HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by instillation.
|
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
|
Placebo Comparator: Part C, Cohort C
Saline placebo by instillation.
|
Saline placebo by injection.
|
Active Comparator: Part C, Cohort D
Bupivacaine HCI (Marcaine), 75 mg by injection.
|
Bupivacaine HCI (Marcaine) by injection.
|
Experimental: Part D, Cohort A
HTX-011B (bupivacaine/meloxicam), 400 mg/13 mg via a combination of injection and instillation.
|
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
|
Experimental: Part E, Cohort A
HTX-009, 12 mg by injection and instillation (combination).
|
HTX-009 by injection and instillation (combination).
|
Experimental: Part F, Cohort A
HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg by instillation.
|
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
|
Experimental: Part F, Cohort B
Bupivacaine HCI (Marcaine), 75 mg by injection.
|
Bupivacaine HCI (Marcaine) by injection.
|
Placebo Comparator: Part F, Cohort C
Saline placebo by injection.
|
Saline placebo by injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Summed Pain Intensity (SPI) Score.
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTX-011-C2015-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on HTX-011
-
Heron TherapeuticsCompleted
-
CelgeneTerminatedBeta Thalassemia Intermedia | Beta Thalassemia MajorFrance, United Kingdom, Italy, Greece
-
Nexel Co., Ltd.Novotech (Australia) Pty LimitedCompleted
-
Hutchison Medipharma LimitedCompletedInflammatory Bowel Diseases
-
Heron TherapeuticsCompletedPostoperative Pain | BunionsUnited States
-
Orionis Biosciences IncRecruiting
-
CelgeneCelgene CorporationTerminatedAdvanced Solid TumorsUnited States
-
Heron TherapeuticsWithdrawn
-
AbbVieCompletedSmall Cell Lung CancerUnited States, Japan, Korea, Republic of, Taiwan
-
Heron TherapeuticsCompletedPostoperative PainUnited States