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

NCT02522598 | Completed Phase 2

• 1 other identifier: PT-VVZ149-04
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity inhibiting GlyT2 and 5HT2A simultaneously. These target receptors have been known to play important roles in induction and transmission of pain signals. There have been many efforts to develop selective drugs to treat pain, but usually unsuccessful due to the lack of efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected to be a dual-target drug, demonstrated having a potential synergism between GlyT2 and 5HT2A to maximize an antinociceptive effect in the in vivo animal models. In Phase 1 conducted among healthy subjects, safety and tolerability were confirmed. Phase 2 was designed as a randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of the analgesic drug VVZ-149 injection.

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (1)

• Change of Numerical Rating Scale using(NRS) a 10-point scale upto 24hr

  prior to administration, at 15 min, 30 min, 1, 2, 4, 6, 8, 10, 24 hours post-dose

Secondary Outcomes (7)

• Difference of Opioid Consumption between Study Groups

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

• Change of Pain Relief (PR) using a 6-point categorical scale upto 24hours

  15min, 30 min, 1, 2, 4, 6, 8, 10, 20, 24 hours post-dose

• Pain Intensity Difference (PID) upto 24hours

  pre-administration of investigational drug and at 15 min, 30 min, 1, 2, 4, 6, 8, 10, 24 hr post dosing

• Sum Pain Intensity Difference over 8hr post- dose (SPID-8)

  pre-administration of investigational drug and at 15 min, 30 min, 1, 2, 4, 6, 8, 10, 24 hr post dosing

• global measurement of patient satisfaction

  8, 24 hours after dosing

Study Arms (2)

VVZ-149 injection

EXPERIMENTAL

VVZ-149 Injections will be mixed with saline,then intravenous infusion for 8hr. The drug product will be administered 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 7.5 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 or water for injection

VVZ-149 injection

Placebo DRUG

water for injection

Also known as: VVZ-149 injection or 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
• Minimal pain intensity (NRS) of ≥5 at initial post-operative measurement.
• 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) 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: August 5, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

KR (1)