Pain, PostoperativePhase 2NCT03997812
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy
A Phase 2 study testing VVZ-149 Injections in people with Pain, Postoperative, run by Vivozon, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- 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
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 May 2019to 21 Aug 2019
- 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 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials
Anaheim, California, 92801
JBR Clinical Research
Salt Lake City, Utah, 84107
About this study
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
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.
- 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
Also called Opiranserin Injections
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.
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion
Using Numeric Pain Rating Scale (NRS, 0-10 at rest)
Measured: 0-12 hours after the start of study drug infusion
Secondary outcomes (6)
AUC of pain intensity for 24 hours after the start of study drug infusion.
Measured: 0-24 hours after the start of study drug infusion
Total opioid consumption up to 12 hours after the start of study drug infusion.
Measured: 0-12 hours after the start of study drug infusion
Total opioid consumption up to 24 hours after the start of study drug infusion.
Measured: 0-24 hours after the start of study drug infusion
Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point.
Measured: 0-24 hours after the start of study drug infusion
Time until the subject requested first and second rescue medications.
Measured: 0-24 hours after the start of study drug infusion
Time to perceptible, meaningful, and confirmed perceptible pain relief.
Measured: 0-12 hours after the start of study drug infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start23 May 2019
- Primary completion7 Aug 2019
- Study completion21 Aug 2019
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 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)
Sponsor and investigators
- Lead sponsor
- Vivozon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doo Lee, PhD, Study chair, Vivozon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997812
- Sponsor's protocol ID
- VVZ149-POP-P2-US004
- Status last verified
- Aug 2020
- First submitted
- 28 May 2019
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03997812
- Acronym / sponsor ID
- VVZ149-POP-P2-US004
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vivozon, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 25 Jun 2019 (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 2 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 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 InjectionsAlso: Opiranserin InjectionsIV infusion of 1000 mg of VVZ-149 | Drug | VVZ-149 Injections |
| PlaceboIV infusion of 0 mg of VVZ-149 | Drug | Placebo |
Primary outcome
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)
6 secondary outcomes
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
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
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
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
Time until the subject requested first and second rescue medications.
Time frame: 0-24 hours after the start of study drug infusion
Time to perceptible, meaningful, and confirmed perceptible pain relief.
Time frame: 0-12 hours after the start of study drug infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Doo Lee, PhD study chair
Vivozon, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VVZ-149 Injections in people with Pain, Postoperative, run by Vivozon, Inc. at 2 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 5 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: 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 2 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?
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). 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 25 Aug 2020.