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Post-Operative PainPhase 2NCT03347266

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

A Phase 2 study testing VVZ-149 injections in people with Post-Operative Pain, run by Vivozon, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Post-Operative Pain
What is being tested?
VVZ-149 injections
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteSouth Korea
Study dates
20 Dec 2017to 19 Jul 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient between the ages of 25 and 65 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
  • Single-side surgery patient

Who cannot join

  • < Surgical Factors >
  • Emergency or unplanned surgery.
  • Repeat operation
  • < Subject Characteristics >
  • Women with childbearing potential, Women who are pregnant or breastfeeding.
  • 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.
Show all 19Show fewer
  • Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).
  • Subjects who have long QPR (>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 6 hour 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 6 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Severance Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
VVZ-149 injections, Placebo
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VVZ-149 injectionsDrug

    Also called Colorless, transparent liquid in water for injection

    •VVZ-149 injection

  • PlaceboDrug

    Also called water for injection

    water for injection

Study groups in NCT03347266
Study groupRoleWhat they receive
VVZ-149 injectionsExperimentalVVZ-149 injections will be mixed with saline, then intravenous infusion for 10hr. The drug product will be administrated with a 1000mg for 10 hours.
Receives: Drug: VVZ-149 injections
PlaceboPlacebo comparatorPlacebo group will receive an water for injection the same volume and period of experimental group.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Pain Intensity

    Change of Pain Intensity assessed using the Numerical Rating Scale (NRS, 0-10)

    Measured: prior to PCA, at 0,1, 2, 4, 6, 8, 10, 24 hours post-PCA

Secondary outcomes (8)

  1. Fentanyl Consumption

    the amount of fentanyl consumption over 24 hours

    Measured: 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

  2. the number of Fentanyl request

    the number of PCA request over 24 hours

    Measured: 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

  3. the amount of rescue dose

    the amount of rescue dose over 24 hours

    Measured: 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

  4. the number of requested rescue dose

    the amount of requested rescue dose over 24 hours

    Measured: 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

  5. Area under a curve (AUC) of Pain intensity and sum of AUC of pain intensity (SPI)

    the calculated AUC of Pain intensity and sum of AUC of pain intensity (SPI)

    Measured: 0-1, 1-2, 2-4, 4-6, 6-8, 8-10, 10-24 hours post-PCA

  6. Global measurement of patient satisfaction assessed on the questionnaire (0-5 points scale)

    the assessment of global satisfaction of patients using 0-5 points scale

    Measured: 8, 24 hours post-PCA

  7. the correlation between Pharmacokinetic (PK) and Pharmacodynamic (PD)

    Correlation between total opioid consumption (fentanyl dose equivalents) and plasma exposure of study drug at 0, 2, 6 hours post-PCA

    Measured: 0, 2, 6 hours post-PCA

  8. Number of Vomiting

    the number of vomiting after PCA

    Measured: 8, 24 hours post-PCA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2017
  2. Study start20 Dec 2017
  3. Primary completion19 Jul 2018
  4. Study completion19 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03347266
Sponsor's protocol ID
PT-VVZ149-06
Status last verified
Nov 2017
First submitted
6 Nov 2017
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VVZ-149 injections in people with Post-Operative Pain, run by Vivozon, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Pain Intensity (time frame: prior to PCA, at 0,1, 2, 4, 6, 8, 10, 24 hours post-PCA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03347266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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