Hallux Valgus DeformityPhase 1NCT03307837
A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity
A Phase 1 study testing CA-008 in people with Hallux Valgus Deformity, run by Concentric Analgesics at 1 site in United States.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus Deformity
- What is being tested?
- CA-008
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2017to 25 Apr 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 - 65 years old, inclusive.
- Planning to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures.
- Be American Society of Anesthesiology (ASA) physical Class 1 or 2.
- In good health and capable of undergoing a bunionectomy under regional anesthesia.
- No additional planned surgeries other than a bunionectomy during the course of the study.
- Male subjects must be either sterile (surgically or biologically), or commit to an acceptable method of birth control while participating in the study.
Show all 14Show fewer
- Female subjects are eligible only if all of the following apply:
- Not pregnant (female subject of child bearing potential must have a negative serum pregnancy tests at screening and negative urine pregnancy test before surgery);
- Not lactating;
- Not planning to become pregnant during the study;
- Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study.
- Have a body mass index ≤ 35 kg/m2.
- Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
- Willing and able to complete the study procedures and pain scales, and to communicate meaningfully in English with study personnel.
Who cannot join
- Subjects with a history of hypertension, cardiovascular disease and a history of cerebrovascular events.
- Subjects with concurrent painful conditions that may require analgesic treatment during the study period, or, in the opinion of the Investigator, may confound post-operative pain assessments.
- Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
- Have a known allergy or intolerance to the following medications or related substances: capsaicin, chili peppers, propofol, bupivacaine, benzodiazepines, midazolam, oxycodone, or ondansetron.
- Have a clinically significant abnormal clinical laboratory test value according to the judgment of the investigator.
- Have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
Show all 27Show fewer
- Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which, in the investigator's opinion, may exert significant analgesic properties or act synergistically with CA-008.
- Use of disallowed pain medications within 2 days prior to Day 1 (NSAIDs, COX-2 inhibitors, tramadol, ketamine, clonidine, gabapentin, pregabalin, or cannabinoids).
- Use of central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, SNRIs, or SSRIs for pain within seven days prior to Day 1. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days prior to Day 1 and is planned to remain stable throughout the study. The use of lorazepam and other sleep medications, except those containing analgesic properties, is permitted.
- Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator, including QTcF >450 for men and >470 for women.
- Use of dietary supplements or over-the-counter (OTC) medications containing significant amounts of capsaicin within 1 day prior to Day 1, and throughout the hospitalization period.
- Subjects with active cutaneous disease, or other disease, at the anticipated site of surgery.
- History of peripheral vascular disease, sickle cell disease, vascular grafts, or vasospastic disorders.
- Use of parenteral or oral corticosteroid(s) within 14 days prior to Day 1.
- Known bleeding disorder or is taking agents affecting coagulation preoperatively. Deep venous thrombosis (DVT) prophylaxis of the surgeon's choice is permitted postoperatively.
- A medical condition that in the investigator's opinion could adversely impact the subject's participation or safety, conduct of the study, or interfere with the pain assessments.
- Diabetes mellitus.
- Use of antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days, or which is not expected to remain stable throughout the study.
- Use of digoxin, warfarin (see exception below), lithium, theophylline preparations, aminoglycosides, and all antiarrhythmics except beta-blockers, and use of anticonvulsants except benzodiazepines within 7 days prior to Day 1 and throughout the study. (Use of warfarin is allowed, at the investigator's discretion, for DVT prophylaxis after the surgery).
- History of illicit drug use, or prescription medicine or alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 2 years, in the opinion of the Investigator.
- Have positive results on the alcohol breath test indicative of alcohol abuse or urine drug screen indicative of illicit drug use (unless results can be explained by a current prescription or acceptable over-the-counter medication at screening as determined by the investigator) at screening, and/or prior to surgery.
- Stable medication regimen for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half-lives of the specific prior medication (or, if half-life is not known, within 48 hours) before dosing with study medication.
- Participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer) prior to the planned bunionectomy surgery, or is scheduled to receive an investigational product other than CA-008 while participating in the study.
- Previously participated in a clinical study with CA-008 or capsaicin.
- Subjects with peripheral neuropathies which would potentially confound the planned neurosensory testing.
- Any past or current medical condition that in opinion of investigator, puts subject at undue safety risk for surgical complications or for use of the investigational product.
- Subjects who donated blood or plasma within the 30 days prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Research, LLC
Pasadena, California, 91105
About this study
Official title: A Phase 1/Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of a Single Intraoperative Administration of CA-008 in Subjects Undergoing Correction of Hallux Valgus Deformity
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study.
The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo. Placebo patients from each cohort were pooled for analysis. The initial cohort will receive the lowest planned dose of CA-008, and sequential cohorts will receive escalating doses of CA-008 in a fixed volume of administration. There will be at least a 6-day period between cohorts, in order to ensure a minimum of 3 days to review safety data from the last subject in a cohort and to allow the meeting of the Data Monitoring Committee (DMC) to review the safety data from the entire cohort prior to a making decision for dose escalation. Dose escalation rules will be protocol defined.
Subjects will be undergoing unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy). In accordance with standard of care, subjects will receive regional anesthesia (MAYO block) with 0.5% bupivacaine. Prior to wound closure, 10 mL of study drug will be injected into the soft tissues and periosteum of the surgical site.
After the surgery, subjects will be monitored for 48 hours at the trial site. Safety and efficacy evaluations will be performed as described herein. Subjects will be required to meet certain pre-specified criteria prior to discharge.
- Conditions
- Hallux Valgus Deformity
- Being tested
- CA-008, Placebo
- Keywords
- Unilateral Transpositional First Metatarsal Osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA-008Drug
Local administration during surgery
PlaceboDrug
Local administration during surgery
| Study group | Role | What they receive |
|---|---|---|
| CA-008 Cohort 1 0.5 mg | Active comparator | Intra-operative, local administration Receives: Drug: CA-008 |
| CA-008 Cohort 2 1 mg | Active comparator | Intra-operative, local administration Receives: Drug: CA-008 |
| CA-008 Cohort 3 2 mg | Active comparator | Intra-operative, local administration Receives: Drug: CA-008 |
| CA-008 Cohort 4 3 mg | Active comparator | Intra-operative, local administration Receives: Drug: CA-008 |
| CA-008 Cohort 5 4.2 mg | Active comparator | Intra-operative, local administration Receives: Drug: CA-008 |
| Placebo | Placebo comparator | Intra-operative, local administration of saline (equivalent volume in active comparator arm) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Assessment
Assessment of skin reactions to determine if any change from 24 to 48 hours.
Measured: 24 and 48 hours post infiltration
Neurosensory Assessment
Change in neurosensory assessments of the skin surrounding the incision.
Measured: 48 hours post infiltration
Secondary outcomes (2)
11-point (0-10) Numerical Pain Rating Scale (NPRS)
Pain as assessed by a standard 11-point (0-10) NPRS (with 10 as the worse outcome) Area under the curve (AUC)
Measured: time 0 to Day 15
Postoperative Use of Analgesics
Use of postoperative analgesic therapy/treatments
Opioid consumption is recorded on the concomitant medication and/or the rescue medications pages and is calculated as the sum of the morphine milligram equivalents (MEQ) of all the medications recorded as taken during the period. For subjects who discontinued from the efficacy portion of the study, all medications are included regardless of whether they were taken before or after the discontinuation
Measured: Daily up through Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start2 Nov 2017
- Primary completion20 Mar 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hallux Valgus DeformityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concentric Analgesics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Donovan, MD, Study director, Concentric Analgesics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307837
- Sponsor's protocol ID
- CA-PS-2017-101
- Status last verified
- Jun 2021
- First submitted
- 3 Oct 2017
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of a Single Intraoperative Administration of CA-008 in Subjects Undergoing Correction of Hallux Valgus Deformity
- ClinicalTrials.gov ID
- NCT03307837
- Acronym / sponsor ID
- CA-PS-2017-101
- Conditions
- Hallux Valgus Deformity
- Keywords
- Unilateral Transpositional First Metatarsal Osteotomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Concentric AnalgesicsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Posted 30 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study.
The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo. Placebo patients from each cohort were pooled for analysis. The initial cohort will receive the lowest planned dose of CA-008, and sequential cohorts will receive escalating doses of CA-008 in a fixed volume of administration. There will be at least a 6-day period between cohorts, in order to ensure a minimum of 3 days to review safety data from the last subject in a cohort and to allow the meeting of the Data Monitoring Committee (DMC) to review the safety data from the entire cohort prior to a making decision for dose escalation. Dose escalation rules will be protocol defined.
Subjects will be undergoing unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy). In accordance with standard of care, subjects will receive regional anesthesia (MAYO block) with 0.5% bupivacaine. Prior to wound closure, 10 mL of study drug will be injected into the soft tissues and periosteum of the surgical site.
After the surgery, subjects will be monitored for 48 hours at the trial site. Safety and efficacy evaluations will be performed as described herein. Subjects will be required to meet certain pre-specified criteria prior to discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CA-008 Cohort 1 0.5 mg | Active comparator | Drug: CA-008Intra-operative, local administration |
| CA-008 Cohort 2 1 mg | Active comparator | Drug: CA-008Intra-operative, local administration |
| CA-008 Cohort 3 2 mg | Active comparator | Drug: CA-008Intra-operative, local administration |
| CA-008 Cohort 4 3 mg | Active comparator | Drug: CA-008Intra-operative, local administration |
| CA-008 Cohort 5 4.2 mg | Active comparator | Drug: CA-008Intra-operative, local administration |
| Placebo | Placebo comparator | Drug: PlaceboIntra-operative, local administration of saline (equivalent volume in active comparator arm) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female aged 18 - 65 years old, inclusive.
- Planning to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures.
- Be American Society of Anesthesiology (ASA) physical Class 1 or 2.
- In good health and capable of undergoing a bunionectomy under regional anesthesia.
- No additional planned surgeries other than a bunionectomy during the course of the study.
Key exclusion criteria (27 listed)
- Subjects with a history of hypertension, cardiovascular disease and a history of cerebrovascular events.
- Subjects with concurrent painful conditions that may require analgesic treatment during the study period, or, in the opinion of the Investigator, may confound post-operative pain assessments.
- Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
- Have a known allergy or intolerance to the following medications or related substances: capsaicin, chili peppers, propofol, bupivacaine, benzodiazepines, midazolam, oxycodone, or ondansetron.
- Have a clinically significant abnormal clinical laboratory test value according to the judgment of the investigator.
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 |
|---|---|---|
| CA-008Local administration during surgery | Drug | CA-008 Cohort 1 0.5 mg, CA-008 Cohort 2 1 mg, CA-008 Cohort 3 2 mg, CA-008 Cohort 4 3 mg, CA-008 Cohort 5 4.2 mg |
| PlaceboLocal administration during surgery | Drug | Placebo |
Primary outcome
Surgical Site Assessment
Time frame: 24 and 48 hours post infiltration
Assessment of skin reactions to determine if any change from 24 to 48 hours.
Neurosensory Assessment
Time frame: 48 hours post infiltration
Change in neurosensory assessments of the skin surrounding the incision.
2 secondary outcomes
11-point (0-10) Numerical Pain Rating Scale (NPRS)
Time frame: time 0 to Day 15
Postoperative Use of Analgesics
Time frame: Daily up through Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hallux Valgus Deformity
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Hallux Valgus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
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.
John Donovan, MD study director
Concentric Analgesics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CA-008 in people with Hallux Valgus Deformity, run by Concentric Analgesics at 1 site 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 14 inclusion and 27 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Surgical Site Assessment (time frame: 24 and 48 hours post infiltration). The study lists 2 primary outcomes in all. 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 30 Jun 2021.