Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Gastrectomy

NCT02844725 | Completed Phase 2

• 1 other identifier: PT-VVZ149-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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, and placebo-controlled study.

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (1)

• Change of Pain Intensity

  Change of Pain Intensity assessed on the Numerical Rating Scale (NRS) using a 10-point scale up to 24 hours

  prior toPCA, at 1, 2, 4, 6, 8, 10, 24 hours post-dose

Secondary Outcomes (3)

• Difference of Opioid Consumption between Study Groups

  0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-dose

• Pain Intensity Difference (PID) using Numerical Pain Rating Scale (NRS, 0-10) up to 24 hours

  1, 2, 4, 6, 8, 10, 24 hours post-dose

• Global measurement of patient satisfaction assessed on the questionnarie (0-5 points scale)

  10, 24 hours post-dose

Study Arms (2)

VVZ-149 injection

EXPERIMENTAL

VVZ-149 injections will be mixed with saline, then intravenous infusion for 10hr. The drug product will be administrated with a loading dose of 1.8 mg/kg for 0.5 hour followed by a maintenance dose of 1.3 mg/kg/h for 9.5 hours.

Drug: VVZ-149 injections

Placebo

PLACEBO COMPARATOR

Placebo group will receive an water for injection the same volume and period of experimental group.

Drug: Placebo

Interventions

VVZ-149 injections DRUG

Colorless, transparent liquid in water for injection

Also known as: VVZ-149 injection

VVZ-149 injection

Placebo DRUG

water for injection

Also known as: water for injection

Placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient between the ages of 25 and 70 years old
• Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing
• Subject who underwent surgery specially for the clinical study
• Ability to provide written informed consent prior to any study procedures.
• Ability to understand study procedures and communicate clearly with the investigator and staff.
• Subjects with body weight under 100kg and body mass index (BMI) level lower than 35 kg/m2, inclusive

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 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).
• Subjects who have long PR (\>200msec) or prolonged QTc (\> 450msec in male, \>470msec in female) at Screening
• \< Drug, Alcohol, and Pharmacological Considerations \>
• History of alcohol, opiate or other drug abuse or dependence within 12 months prior to 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.

Sponsors & Collaborators

• Vivozon, Inc.: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Water; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Seonjun Bae, MD, PhD

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: July 26, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

KR (1)