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Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Postoperative Pain Following Total Hip Arthroplasty.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347266
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Vivozon, Inc.

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.

Condition or disease Intervention/treatment Phase
Post-Operative Pain Drug: VVZ-149 injections Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Total Hip Arthroplasty
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 19, 2018

Arm Intervention/treatment
Experimental: VVZ-149 injections
VVZ-149 injections will be mixed with saline, then intravenous infusion for 10hr. The drug product will be administrated with a 1000mg for 10 hours.
Drug: VVZ-149 injections
•VVZ-149 injection
Other Name: Colorless, transparent liquid in water for injection

Placebo Comparator: Placebo
Placebo group will receive an water for injection the same volume and period of experimental group.
Drug: Placebo
water for injection
Other Name: water for injection




Primary Outcome Measures :
  1. Change of Pain Intensity [ Time Frame: prior to PCA, at 0,1, 2, 4, 6, 8, 10, 24 hours post-PCA ]
    Change of Pain Intensity assessed using the Numerical Rating Scale (NRS, 0-10)


Secondary Outcome Measures :
  1. Fentanyl Consumption [ 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-PCA ]
    the amount of fentanyl consumption over 24 hours

  2. the number of Fentanyl request [ 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-PCA ]
    the number of PCA request over 24 hours

  3. the amount of rescue dose [ 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 ]
    the amount of rescue dose over 24 hours

  4. the number of requested rescue dose [ 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 ]
    the amount of requested rescue dose over 24 hours

  5. Area under a curve (AUC) of Pain intensity and sum of AUC of pain intensity (SPI) [ Time Frame: 0-1, 1-2, 2-4, 4-6, 6-8, 8-10, 10-24 hours post-PCA ]
    the calculated AUC of Pain intensity and sum of AUC of pain intensity (SPI)

  6. Global measurement of patient satisfaction assessed on the questionnaire (0-5 points scale) [ Time Frame: 8, 24 hours post-PCA ]
    the assessment of global satisfaction of patients using 0-5 points scale

  7. the correlation between Pharmacokinetic (PK) and Pharmacodynamic (PD) [ Time Frame: 0, 2, 6 hours post-PCA ]
    Correlation between total opioid consumption (fentanyl dose equivalents) and plasma exposure of study drug at 0, 2, 6 hours post-PCA

  8. Number of Vomiting [ Time Frame: 8, 24 hours post-PCA ]
    the number of vomiting after PCA



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient between the ages of 25 and 65 years old
  2. Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing
  3. Subject who underwent surgery specially for the clinical study
  4. Ability to provide written informed consent prior to any study procedures.
  5. Ability to understand study procedures and communicate clearly with the investigator and staff.
  6. Subjects with body weight under 100kg and body mass index (BMI) level lower than 35 kg/m2, inclusive
  7. Single-side surgery patient

Exclusion Criteria:

< Surgical Factors >

  1. Emergency or unplanned surgery.
  2. Repeat operation

    < Subject Characteristics >

  3. Women with childbearing potential, Women who are pregnant or breastfeeding.
  4. Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD, anxiety, or depression). Subjects who take stable doses of antidepressants and anti-anxiety drugs may be included.
  5. Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).
  6. Subjects who have long QPR (>200msec) or prolonged QTc (> 450msec in male, >470msec in female) at Screening

    < Drug, Alcohol, and Pharmacological Considerations >

  7. History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening .
  8. Ongoing or recent (within 6 hour prior to surgery) use of steroids, opioids, or antipsychotics.
  9. Alcohol consumption within 24 hours of surgery.
  10. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 6 hours of surgery.
  11. 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 >

  12. Use of neuraxial or regional anesthesia related to the surgery.
  13. Use of ketamine, gabapentin, pregabalin, or lidocaine (>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery.
  14. Subject with known allergies to hydromorphone.
  15. Subjects who received another investigational drug within 30 days of scheduled surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347266


Locations
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Korea, Republic of
Yonsei University Health System, Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Vivozon, Inc.
Investigators
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Principal Investigator: Seonjun Bae, MD, PhD Yonsei University Health System, Severance Hospital

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Responsible Party: Vivozon, Inc.
ClinicalTrials.gov Identifier: NCT03347266    
Other Study ID Numbers: PT-VVZ149-06
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs