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

Primary Purpose

Post-Operative Pain

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

VVZ-149 injections

Placebo

About this trial

This is an interventional treatment trial for Post-Operative Pain

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

< 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.
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 ketamine, gabapentin, pregabalin, or lidocaine (>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery.
Subject with known allergies to hydromorphone.
Subjects who received another investigational drug within 30 days of scheduled surgery

Sites / Locations

Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VVZ-149 injection

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change of Pain Intensity

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

Secondary Outcome Measures

Difference of Opioid Consumption between Study Groups

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

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

Full Information

NCT ID

NCT02844725

First Posted

July 17, 2016

Last Updated

October 31, 2017

Sponsor

Vivozon, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02844725

Brief Title

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

Official Title

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Stdy to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Laparoscopic or Robotic-assisted Laparoscopic Gastrectomy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vivozon, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to the brain. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain transmission by the brain and reduces nociceptor activation in peripheral nerves, which are primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable efficacy to morphine in well controlled (blind, complete randomization with a positive control) animal studies using rat models of post-operative pain and formalin-induced pain. The PK/PD study in animals indicates that therapeutic plasma concentration in human subjects will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure level is more than 2,000 ng/ml.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Operative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VVZ-149 injection

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

VVZ-149 injections

Other Intervention Name(s)

VVZ-149 injection

Intervention Description

Colorless, transparent liquid in water for injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

water for injection

Intervention Description

water for injection

Primary Outcome Measure Information:

Title

Change of Pain Intensity

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Difference of Opioid Consumption between Study Groups

Time Frame

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

Title

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

Time Frame

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

Title

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

Time Frame

10, 24 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: < 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. 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 ketamine, gabapentin, pregabalin, or lidocaine (>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery. Subject with known allergies to hydromorphone. Subjects who received another investigational drug within 30 days of scheduled surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seonjun Bae, MD, PhD

Organizational Affiliation

Yonsei University Health System, Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei University Health System, Severance Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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

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