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

• Sponsor: Heron Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02504580
• Collaborator: (none)
• Enrollment: 463
• Locations: 3
• Arms: 23
• Actual Duration (Months): 21
• Patients Per Site: 154.3
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Analgesia in Patients With Inguinal Herniorrhaphy	Drug: HTX-011; Drug: Placebo; Drug: HTX-002; Drug: Bupivacaine Hydrochloride Injection; Drug: HTX-011A; Drug: HTX-011B; Drug: HTX-009; Drug: Marcaine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 463 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A Cohort A 200 mg of HTX-011 by injection	Drug: HTX-011
Experimental: Part A Cohort B 400 mg of HTX-011 by injection	Drug: HTX-011
Experimental: Part A Cohort C 200 mg of HTX-011 by instillation	Drug: HTX-011
Experimental: Part A Cohort D 400 mg of HTX-011 by instillation	Drug: HTX-011
Experimental: Part A Cohort E 200 mg HTX-011 injection and 200 mg instillation	Drug: HTX-011
Placebo Comparator: Part A Cohort F Saline solution by injection	Drug: Placebo
Experimental: Part B Cohort A 200 mg HTX-011A by injection	Drug: HTX-011A
Experimental: Part B Cohort B 400 mg HTX-011A by injection	Drug: HTX-011A
Experimental: Part B Cohort C 200 mg HTX-011B by injection	Drug: HTX-011B
Experimental: Part B Cohort D 400 mg HTX-011B by injection	Drug: HTX-011B
Placebo Comparator: Part B Cohort E Saline solution by injection	Drug: Placebo
Experimental: Part C Cohort A 200 mg HTX-002 by infiltration	Drug: HTX-002
Experimental: Part B Cohort F 400 mg HTX-002 by infiltration	Drug: HTX-002
Experimental: Part C Cohort B 200 mg HTX-011B by instillation	Drug: HTX-011B
Experimental: Part B Cohort G 400 mg HTX-011B by instillation	Drug: HTX-011B
Placebo Comparator: Part C Cohort C Saline Solution by instillation	Drug: Placebo
Active Comparator: Part C Cohort D 0.25% bupivacaine hydrochloride injection	Drug: Bupivacaine Hydrochloride Injection
Experimental: Part D Cohort A 400 mg HTX-011B via a combination of injection and instillation	Drug: HTX-011B
Experimental: Part E Cohort A HTX-009 by injection	Drug: HTX-009
Experimental: Part E Cohort B HTX-009 by instillation	Drug: HTX-009
Experimental: Part F Cohort A 300 mg of HTX-011B	Drug: HTX-011B
Experimental: Part F Cohort B 75 mg of 0.25% Marcaine	Drug: Marcaine
Placebo Comparator: Part F Cohort C 10.26 mL of normal saline	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Efficacy endpoint (Summed pain intensity (SPI) [24 Hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Plan to undergo a unilateral inguinal herniorrhaphy

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

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anaheim	California	United States	92801
2		Houston	Texas	United States	77004
3		Houston	Texas	United States	77027

Sponsors and Collaborators

• Heron Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heron Therapeutics
• ClinicalTrials.gov Identifier: NCT02504580
• Other Study ID Numbers: HTX-011-C2015-202
• First Posted: Jul 22, 2015
• Last Update Posted: Jun 12, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Hernia, Inguinal; Bupivacaine

Study Results

No Results Posted as of Jun 12, 2018