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

NCT02489526 | Completed Phase 2

• 1 other identifier: VVZ149-POP-P2-US001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference over 8-hours post-dose (SPID8)

  SPID8 using Numerical Pain Rating Scale (NRS, 0-10) measured up to 8 hours post-dose

  8 hours post-dose

Secondary Outcomes (6)

• Difference of Opioid Consumption between Study Groups

  0-2, 2-4, 4-6, 6-8, 8-12, 12-16, and 16-24 hours post-dose

• Change of Pain Intensity (NRS)

  9 and 24 hours post-dose

• Change of Pain Relief (PR) assessed using a 6-point categorical scale

  9 and 24 hours post-dose

• Comparison of Global Measurement of Subject Satisfaction between Study Groups

  8 and 24 hours post-dose

• Change of Richmond Agitation-Sedation Scale

  9 and 24 hours post-dose

Study Arms (2)

VVZ-149 Injections

EXPERIMENTAL

Drug: VVZ-149 Injections

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

VVZ-149 Injections DRUG

Experimental group will receive a loading dose of 1.8 mg/kg VVZ-149 intravenous infusion for 0.5 hour followed by a maintenance dose of 1.3 mg/kg/h VVZ-149 intravenous infusion for 7.5 hours.

Also known as: Opiranserin Injections

VVZ-149 Injections

Placebo DRUG

Placebo group will receive the corresponding amount of placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vivozon, Inc.: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• Nedeljkovic SS, Song I, Bao X, Zeballos JL, Correll DJ, Zhang Y, Ledley JS, Bhandari A, Bai X, Lee SR, Cho S. Exploratory study of VVZ-149, a novel analgesic molecule, in the affective component of acute postoperative pain after laparoscopic colorectal surgery. J Clin Anesth. 2022 Feb;76:110576. doi: 10.1016/j.jclinane.2021.110576. Epub 2021 Nov 15.

  PMID: 34794108 DERIVED

• Song I, Cho S, Nedeljkovic SS, Lee SR, Lee C, Kim J, Bai SJ. Role of VVZ-149, a Novel Analgesic Molecule, in the Affective Component of Pain: Results from an Exploratory Proof-of-Concept Study of Postoperative Pain following Laparoscopic and Robotic-Laparoscopic Gastrectomy. Pain Med. 2021 Sep 8;22(9):2037-2049. doi: 10.1093/pm/pnab066.

  PMID: 33624798 DERIVED

• Nedeljkovic SS, Correll DJ, Bao X, Zamor N, Zeballos JL, Zhang Y, Young MJ, Ledley J, Sorace J, Eng K, Hamsher CP, Maniam R, Chin JW, Tsui B, Cho S, Lee DH. Randomised, double-blind, parallel group, placebo-controlled study to evaluate the analgesic efficacy and safety of VVZ-149 injections for postoperative pain following laparoscopic colorectal surgery. BMJ Open. 2017 Feb 17;7(2):e011035. doi: 10.1136/bmjopen-2016-011035.

  PMID: 28213593 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 3, 2015
• Study Start: September 28, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 15, 2016
• Last Updated: August 25, 2020

Record last verified: 2019-03

Locations

US (3)