Clinical trial NCT03997812: Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Lead sponsor: Vivozon, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion
timeFrame: 0-12 hours after the start of study drug infusion
Secondary outcomes:
measure: AUC of pain intensity for 24 hours after the start of study drug infusion.
timeFrame: 0-24 hours after the start of study drug infusion
measure: Total opioid consumption up to 12 hours after the start of study drug infusion.
timeFrame: 0-12 hours after the start of study drug infusion
measure: Total opioid consumption up to 24 hours after the start of study drug infusion.
timeFrame: 0-24 hours after the start of study drug infusion
measure: Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point.
timeFrame: 0-24 hours after the start of study drug infusion
measure: Time until the subject requested first and second rescue medications.
timeFrame: 0-24 hours after the start of study drug infusion
measure: Time to perceptible, meaningful, and confirmed perceptible pain relief.
timeFrame: 0-12 hours after the start of study drug infusion
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
affiliation: Vivozon, Inc.
name: Doo Lee, PhD
role: STUDY_CHAIR
References: