Pain, PostoperativePhase 3NCT04430088
Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy
A Phase 3 study testing VVZ-149 Injections in people with Pain, Postoperative, run by Vivozon, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- 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
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jun 2020to Jan 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
California Clinical Trial Site
Anaheim, California, 92801
- Recruiting
Arizona Clinical Trial Site
Phoenix, Arizona, 85053
- Recruiting
Texas Clinical Trial Site
San Antonio, Texas, 78229
About this study
Official title: 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
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.
- Conditions
- Pain, Postoperative
- 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
IV infusion of 1000 mg of VVZ-149
PlaceboDrug
IV infusion of 0 mg of VVZ-149
| Study group | Role | What they receive |
|---|---|---|
| VVZ-149 Injections | Experimental | Not described Receives: Drug: VVZ-149 Injections |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0-12 hours post-dose
Secondary outcomes (4)
Time to onset of perceptible pain relief using the double stopwatch method
Measured: 0-12 hours post-dose
Total number of rescue medication request between 0-12 hours post-dose
Measured: 0-12 hours post-dose
Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose
Measured: 0-6 hours post-dose
Proportion of patients who take prescription opioid after discharge
Measured: 2 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start26 Jun 2020
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivozon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430088
- Sponsor's protocol ID
- VVZ149-POP-P3-US005
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04430088
- Acronym / sponsor ID
- VVZ149-POP-P3-US005
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vivozon, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VVZ-149 Injections | Experimental | Drug: VVZ-149 Injections |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VVZ-149 InjectionsIV infusion of 1000 mg of VVZ-149 | Drug | VVZ-149 Injections |
| PlaceboIV infusion of 0 mg of VVZ-149 | Drug | Placebo |
Primary outcome
Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
Time frame: 0-12 hours post-dose
Using Numeric Pain Rating Scale (NRS, 0-10)
4 secondary outcomes
Time to onset of perceptible pain relief using the double stopwatch method
Time frame: 0-12 hours post-dose
Total number of rescue medication request between 0-12 hours post-dose
Time frame: 0-12 hours post-dose
Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose
Time frame: 0-6 hours post-dose
Proportion of patients who take prescription opioid after discharge
Time frame: 2 weeks after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VVZ-149 Injections in people with Pain, Postoperative, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Operations (+1-609-269-9140, clinicaltrials@vivozon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose) (time frame: 0-12 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2020.