Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery

• Status: Completed
• Trial end date: 2016-08-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, placebo-controlled study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivozon, Inc.
• Treatments: Analgesics

Criteria

Inclusion Criteria:

1. Men and women age between 18-70, inclusive.

2. Pain intensity (NRS) ≥4 at initial post-operative measurement in PACU.

3. Subjects undergoing planned laparoscopic colorectal surgery.

4. Ability to provide written informed consent.

5. Ability to understand study procedures and communicate clearly with the investigator and staff.

6. American Society of Anesthesiologists (ASA) risk class of I to III.

Exclusion Criteria:

< Surgical Factors >

1. Emergency or unplanned surgery.

2. Repeat operation (e.g., previous surgery within 30 days for same condition).

3. Cancer-related condition causing preoperative pain in site of surgery.

< Subject Characteristics >

4. Women with childbearing potential (Women age 18-55 must undergo pregnancy test).

5. Women who are pregnant or breastfeeding.

6. Chronic pain diagnosis (e.g., ongoing pain at baseline with NRS ≥ 4/10).

7. Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD, anxiety, or depression) Subjects who take stable doses (same dose >30 days) of antidepressants and anti-anxiety drugs may be included.

8. Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).

< Drug, Alcohol, and Pharmacological Considerations >

9. Renal or hepatic impairment.

10. History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening (TICS alcohol/drug screen will be performed at Screening).

11. Ongoing or recent (within 30 days prior to surgery) use of steroids, opioids, or antipsychotics.

12. Alcohol consumption within 24 hours of surgery.

13. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 24 hours of surgery.

14. Use of herbal agents or nutraceuticals (i.e., chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian) within 7 days prior to surgery.

< Anesthetic and Other Exclusion Considerations >

15. Use of neuraxial or regional anesthesia related to the surgery.

16. Use of local anesthetic wound infiltration > 20 ml of 1% lidocaine

17. Use of ketamine, gabapentin, pregabalin, or lidocaine (>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery.

18. Subjects with known allergies to hydromorphone.

19. Subjects who received another investigational drug within 30 days of scheduled surgery.

20. Subjects who have long PR (>200 msec) or prolonged QTc (> 450 msec) at Screening or on an EKG done immediately prior to dosing.