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

Completed · Phase 2 · Has a placebo group

Conditions studied: Post-Operative Pain

In brief

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.

Key facts

Study ID

NCT02489526

Run by

Vivozon, Inc.

People needed

60

Starts

2015-09-28

Expected to finish

2016-08-15

Last updated by the study team

2020-08-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women age between 18-70, inclusive.
• Pain intensity (NRS) ≥4 at initial post-operative measurement in PACU.
• 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.

You may not qualify if…

• < Surgical Factors >
• 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.
• < Subject Characteristics >
• Women with childbearing potential (Women age 18-55 must undergo pregnancy test).
• 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 (same dose >30 days) of antidepressants and anti-anxiety drugs may be included.
• Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).
• < Drug, Alcohol, and Pharmacological Considerations >
• 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 steroids, opioids, or antipsychotics.
• Alcohol consumption within 24 hours of surgery.
• Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 24 hours of surgery.
• 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 >
• 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) at Screening or on an EKG done immediately prior to dosing.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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