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Post-Operative PainPhase 2NCT02489526

Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery

A Phase 2 study testing VVZ-149 Injections in people with Post-Operative Pain, run by Vivozon, Inc. at 3 sites in United States.

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, placebo-controlled study. Read more about this study

Who is it for?
Ages 18 to 70 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
60 participants
Where
3 sitesUnited States
Study dates
28 Sep 2015to 15 Aug 2016
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women age between 18-70, inclusive.
  • Pain intensity (NRS) ≥4 at initial post-operative measurement in PACU.
  • Subjects undergoing planned laparoscopic colorectal surgery.
  • Ability to provide written informed consent.
  • Ability to understand study procedures and communicate clearly with the investigator and staff.
  • American Society of Anesthesiologists (ASA) risk class of I to III.

Who cannot join

  • < 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 age 18-55 must undergo pregnancy test).
Show all 24Show fewer
  • 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).
  • < Drug, Alcohol, and Pharmacological Considerations >
  • Renal or hepatic impairment.
  • History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening (TICS alcohol/drug screen will be performed at 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 local anesthetic wound infiltration > 20 ml of 1% lidocaine
  • Use of ketamine, gabapentin, pregabalin, or lidocaine (>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery.
  • Subjects with known allergies to hydromorphone.
  • Subjects who received another investigational drug within 30 days of scheduled surgery.
  • Subjects who have long PR (>200 msec) or prolonged QTc (> 450 msec) at Screening or on an EKG done immediately prior to dosing.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectal Surgery

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, 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 Opiranserin Injections

    Experimental group will receive a loading dose of 1.8 mg/kg VVZ-149 intravenous infusion for 0.5 hour followed by a maintenance dose of 1.3 mg/kg/h VVZ-149 intravenous infusion for 7.5 hours.

  • PlaceboDrug

    Placebo group will receive the corresponding amount of placebo.

Study groups in NCT02489526
Study groupRoleWhat they receive
VVZ-149 InjectionsExperimentalNot described
Receives: Drug: VVZ-149 Injections
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Sum of Pain Intensity Difference over 8-hours post-dose (SPID8)

    SPID8 using Numerical Pain Rating Scale (NRS, 0-10) measured up to 8 hours post-dose

    Measured: 8 hours post-dose

Secondary outcomes (6)

  1. Difference of Opioid Consumption between Study Groups

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

  2. Change of Pain Intensity (NRS)

    Measured: 9 and 24 hours post-dose

  3. Change of Pain Relief (PR) assessed using a 6-point categorical scale

    Measured: 9 and 24 hours post-dose

  4. Comparison of Global Measurement of Subject Satisfaction between Study Groups

    Measured: 8 and 24 hours post-dose

  5. Change of Richmond Agitation-Sedation Scale

    Measured: 9 and 24 hours post-dose

  6. Change of Incidence of Postoperative Nausea and Vomiting

    Measured: 8 and 24 hours post-dose

Timeline

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

  1. First posted3 Jul 2015 (estimated)
  2. Study start28 Sep 2015
  3. Primary completionAug 2016
  4. Study completion15 Aug 2016

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02489526
Sponsor's protocol ID
VVZ149-POP-P2-US001
Status last verified
Mar 2019
First submitted
18 Jun 2015
Last updated
25 Aug 2020
Results posted
No
Data monitoring committee
No

Publications

  • Nedeljkovic SS, Song I, Bao X, Zeballos JL, Correll DJ, Zhang Y, Ledley JS, Bhandari A, Bai X, Lee SR, Cho S. Exploratory study of VVZ-149, a novel analgesic molecule, in the affective component of acute postoperative pain after laparoscopic colorectal surgery. J Clin Anesth. 2022 Feb;76:110576. doi: 10.1016/j.jclinane.2021.110576. Epub 2021 Nov 15.

    PubMed 34794108

  • Song I, Cho S, Nedeljkovic SS, Lee SR, Lee C, Kim J, Bai SJ. Role of VVZ-149, a Novel Analgesic Molecule, in the Affective Component of Pain: Results from an Exploratory Proof-of-Concept Study of Postoperative Pain following Laparoscopic and Robotic-Laparoscopic Gastrectomy. Pain Med. 2021 Sep 8;22(9):2037-2049. doi: 10.1093/pm/pnab066.

    PubMed 33624798

  • Nedeljkovic SS, Correll DJ, Bao X, Zamor N, Zeballos JL, Zhang Y, Young MJ, Ledley J, Sorace J, Eng K, Hamsher CP, Maniam R, Chin JW, Tsui B, Cho S, Lee DH. Randomised, double-blind, parallel group, placebo-controlled study to evaluate the analgesic efficacy and safety of VVZ-149 injections for postoperative pain following laparoscopic colorectal surgery. BMJ Open. 2017 Feb 17;7(2):e011035. doi: 10.1136/bmjopen-2016-011035.

    PubMed 28213593

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 3 sites in United States.

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 6 inclusion and 24 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Sum of Pain Intensity Difference over 8-hours post-dose (SPID8) (time frame: 8 hours post-dose). 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 NCT02489526, which also lists 3 linked publications.

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 25 Aug 2020.

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