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Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

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ClinicalTrials.gov Identifier: NCT03997812
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 26, 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 for treating post-operative pain following bunionectomy.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: VVZ-149 Injections Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: VVZ-149 Injections Drug: VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
Other Name: Opiranserin Injections

Placebo Comparator: Placebo Drug: Placebo
IV infusion of 0 mg of VVZ-149




Primary Outcome Measures :
  1. Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion [ Time Frame: 0-12 hours after the start of study drug infusion ]
    Using Numeric Pain Rating Scale (NRS, 0-10 at rest)


Secondary Outcome Measures :
  1. AUC of pain intensity for 24 hours after the start of study drug infusion. [ Time Frame: 0-24 hours after the start of study drug infusion ]
  2. Total opioid consumption up to 12 hours after the start of study drug infusion. [ Time Frame: 0-12 hours after the start of study drug infusion ]
  3. Total opioid consumption up to 24 hours after the start of study drug infusion. [ Time Frame: 0-24 hours after the start of study drug infusion ]
  4. Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point. [ Time Frame: 0-24 hours after the start of study drug infusion ]
  5. Time until the subject requested first and second rescue medications. [ Time Frame: 0-24 hours after the start of study drug infusion ]
  6. Time to perceptible, meaningful, and confirmed perceptible pain relief. [ Time Frame: 0-12 hours after the start of study drug infusion ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women must be between the ages of 18 to 70 years, inclusive. Female subjects must meet additional criteria in relation to childbearing potential.
  • Subjects must be undergoing a planned bunionectomy without collateral procedures.
  • Subjects must have the ability to provide written informed consent.
  • Subjects must have the ability to understand study procedures and communicate clearly with the Investigator and staff.
  • Subjects must be classified as American Society of Anesthesiologists risk class I to II.

Exclusion Criteria:

  • Subjects undergoing emergency or unplanned surgery.
  • Subjects undergoing a repeat operation.
  • Subjects with pre-existing conditions (other than bunion) causing preoperative pain at the site of surgery.
  • Female subjects who are pregnant or breastfeeding.
  • Diagnosis of chronic pain and ongoing or frequent use of pain medications.

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): NCT03997812


Contacts
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Contact: Shiela Caluag, RN 6092699140 scaluag@vivozon.com

Locations
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United States, California
Anaheim Clinical Trials Recruiting
Anaheim, California, United States, 92801
United States, Utah
JBR Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Vivozon, Inc.
Investigators
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Study Chair: Doo Lee, PhD Vivozon, Inc.

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Responsible Party: Vivozon, Inc.
ClinicalTrials.gov Identifier: NCT03997812     History of Changes
Other Study ID Numbers: VVZ149-POP-P2-US004
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
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