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

• Status: Completed
• Trial end date: 2018-04-26
• 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:

• Subjects undergoing planned laparoscopic colorectal surgery.

• Ability to provide written informed consent.

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

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

Exclusion Criteria:

• Emergency or unplanned surgery.

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

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

• Surgical duration (from incision to end of closure) > 5 hours.

• Women with childbearing potential (age 18-55) must undergo blood pregnancy test at screening and then a urine pregnancy test preoperatively on day of surgery. Women with a positive pregnancy test will be excluded. Women of childbearing potential must agree to use at least one effective contraceptive method upon enrollment and for 30 days following the last dose of the investigational product.

• Women who are pregnant or breastfeeding.

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

• Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD, anxiety, or depression) Subjects who take stable doses of antidepressants and anti-anxiety drugs, or procedure-related anti-anxiety drugs may be included.

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

• Body weight under 55 kg.

• Renal or hepatic impairment.

• 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).

• Ongoing or recent (within 30 days prior to surgery) use of opioids or antipsychotics. However, subjects who receive procedure-related opioids (i.e., for a preoperative colonoscopy) may be included.

• Alcohol consumption within 24 hours of surgery.

• Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 24 hours of surgery. Exception: use of aspirin for cardiovascular prophylaxis is acceptable.

• 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.

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

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

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

• Subjects with known allergies to hydromorphone.

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

• Subjects who have long PR (>200 msec) or prolonged QTc (> 450 msec for males and > 470 msec for females) at Screening.