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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504580
• Other study ID #: HTX-011-C2015-202
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: April 2017

Study information

• Verified date: September 2023
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This study includes multiple formulations for formulation selection of the fixed-combination product and for the factorial design assessment of the contribution of each component. HTX-011 is the initial formulation studied (HTX-011-19). HTX-011A is the second formulation studied (HTX-011-49). HTX-011B is the final formulation studied (HTX-011-56), which was also included in subsequent Phase 2b and Phase 3 studies. For the factorial design assessment, HTX-002, a bupivacaine-only formulation in the same HTX-011 proprietary polymer, and HTX-009, a meloxicam-only formulation in the same HTX-011 proprietary polymer, were evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be male or female 18 years of age or older.

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 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.

3. Plan to undergo a unilateral inguinal herniorrhaphy

4. Have the ability and be willing to comply with the study procedures

5. 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:

1. Unwilling to sign informed consent or not willing or able to complete all study procedures

2. Have a contraindication or be allergic to any medication to be used during the trial period

3. 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

4. Have American Society of Anesthesiologists (ASA) Physical Status classification system category 4 or greater (Appendix E)

5. Have clinically significant renal or hepatic abnormalities (defined as an AST or ALT > 3x ULN, creatinine > 2x ULN)

6. Have another painful condition that may confound pain assessments

7. 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

8. Have a known or suspected history of alcohol or drug abuse, or a positive drug screen

9. 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

10. Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)

11. Female subjects who are pregnant (positive pregnancy test at screening or on the day of surgery)

12. Subjects who are receiving oxygen therapy at the time of screening

13. Have participated in a clinical trial within 30 days of planned surgery

14. Have a body mass index (BMI) > 39 kg/m2

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• HTX-011
HTX-011 (bupivacaine/meloxicam) by injection.
• Placebo
Saline placebo by injection.
• HTX-002
HTX-002, by injection or instillation (pooled).
• Bupivacaine HCI (Marcaine)
Bupivacaine HCI (Marcaine) by injection.
• HTX-011A
HTX-011A (bupivacaine/meloxicam) by injection.
• HTX-011B
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
• HTX-009
HTX-009 by injection and instillation (combination).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Summed Pain Intensity (SPI) Score.	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