Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy
A Phase 3, 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
1 other identifier
interventional
300
1 country
3
Brief Summary
The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2020
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
June 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJuly 23, 2020
June 1, 2020
5 months
June 9, 2020
July 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
Using Numeric Pain Rating Scale (NRS, 0-10)
0-12 hours post-dose
Secondary Outcomes (4)
Time to onset of perceptible pain relief using the double stopwatch method
0-12 hours post-dose
Total number of rescue medication request between 0-12 hours post-dose
0-12 hours post-dose
Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose
0-6 hours post-dose
Proportion of patients who take prescription opioid after discharge
2 weeks after discharge
Study Arms (2)
VVZ-149 Injections
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Men and women must be at least 18 years of age. Female subjects must meet additional criteria in relation to childbearing potential.
- Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and internal fixation (Austin 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.
You may not qualify if:
- Subjects undergoing emergency or unplanned surgery.
- Subjects who had any previous bunionectomy procedure on either foot.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vivozon, Inc.lead
Study Sites (3)
Arizona Clinical Trial Site
Phoenix, Arizona, 85053, United States
California Clinical Trial Site
Anaheim, California, 92801, United States
Texas Clinical Trial Site
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 12, 2020
Study Start
June 26, 2020
Primary Completion
December 1, 2020
Study Completion
January 1, 2021
Last Updated
July 23, 2020
Record last verified: 2020-06