Pain, PostoperativePhase 1NCT04826328

Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy

A Phase 1 study testing FX301 and Normal Saline in people with Pain, Postoperative and Bunion, run by Pacira Pharmaceuticals, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pain, Postoperative, Bunion
What is being tested?: FX301 and Normal Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 85 participants
Where: 1 siteUnited States
Study dates: 15 Mar 2021to 30 Mar 2022
Phase: Phase 1
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written consent to participate in the study
Be willing and able to complete study procedures and pain scales, follow instructions and communicate meaningfully in English with study personnel, and return for outpatient follow-up visits as required.
Male or female ≥18 to ≤65 years of age, inclusive
Planning to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation, without collateral procedure or additional surgeries, to be performed under Monitored Anesthesia Care (MAC) and be eligible to receive a popliteal sciatic nerve block
Classified as either ASA 1 or ASA 2 by the American Society of Anesthesiologists Physical Status Classification System (Appendix 1).
Has a BMI of ≥18 to ≤ 35 kg/m2.

Show all 15Show fewer

Willing to washout from all prohibited medications for the longer of 14 days or five half-lives prior to dosing, and abstain from those medications through the end of study (Appendix 5).
If a male, unless he has a same sex partner, be either sterile (surgically or biologically) or commit to an acceptable method of birth control while participating in the study.
If a woman of childbearing potential (WOCBP), must meet all of the following:
Not be pregnant (WOCBP must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery);
Not plan to become pregnant or to breast feed during the study; and
Be surgically sterile (at least one year post total hysterectomy, bilateral oophorectomy or bilateral tubal ligation) or at least one year post-menopausal, have a monogamous partner who is surgically sterile, have a same sex partner, or (one of the following must apply):
is practicing double-barrier contraception
is practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity)
is using a non-hormonal contraceptive approved by the FDA for at least 2 months prior to screening and commits to the use of an acceptable form of birth control while participating in the study..

Who cannot join

Has a concurrent painful condition, other than bunion-related pain, that may require analgesic treatment during the study period or may confound post-surgical pain assessments.
Has an active skin disease or other clinically significant abnormality at the anticipated site of surgery or nerve block insertion site that could interfere with the planned surgery.
Has had previous bunionectomy or other surgical procedure on the index foot that could impact the current bunion surgery.
Has any clinically significant cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the investigator, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any NSAIDs; history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to any other drugs used in the study, including anesthetics and antibiotics that may be required on the day of surgery.
Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.

Show all 23Show fewer

Has taken any opioids, NSAIDS, or acetaminophen within 3 days prior to the scheduled surgery. Low dose aspirin (<100 mg) for cardiovascular protection is acceptable.
Has initiated treatment with any of the following medications within 30 days prior to study medication administration or is taking any of these medications to control pain: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, or cyclooxygenase-2 inhibitors. (Note: If a subject is taking one of these medications for a reason other than pain control, the subject must be on a stable scheduled dose [i.e., not "as needed"] for at least 1 month prior to study medication administration.)
Within the 14 days prior to surgery, be taking parenteral or oral corticosteroids (steroid inhalers for allergy or asthma treatment, topical steroids for a non-clinically significant skin condition not involving the area of surgery, or ophthalmic steroids are permissible).
Is currently receiving antianginal therapy
Has a known or suspected history of alcoholism or drug abuse or misuse within 1 year of screening or evidence of opioid tolerance or physical dependence before dosing with the study medication.
Has positive results on the alcohol test (breath or saliva) indicative of alcohol abuse or urine drug screen (UDS) indicative of illicit drug use at screening, and/or prior to surgery. Note that for those subjects have a history of, or who test positive for tetrahydrocannabinol (THC), if they are willing to abstain from use or consumption of THC-containing products from 14 days prior to surgery to Day 85, they may be allowed to participate in the study. Additionally, it may be permissible for the subject to participate if the results of the UDS can be explained by a current prescription or acceptable over-the-counter medication as determined by the investigator at screening and/or prior to surgery.
Has significant difficulties swallowing tablets or is unable to tolerate oral medication.
Has received any investigational drug or device or investigational therapy within the last 30 days.
Has a history of a clinically significant (in the investigator's opinion) GI event within 6 months before screening or has any history of peptic or gastric ulcers or GI bleeding.
Has a surgical or medical condition of the GI or renal system that might significantly alter the absorption, distribution, or excretion of any drug substance.
Is considered by the investigator to be an unsuitable candidate to receive the study medication for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the IB).
Is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 2 years before screening (excluding squamous or basal cell carcinoma of the skin that has been clinically stable and/or fully excised in a curative procedure).
Has significant renal disease, as indicated by clinical laboratory assessment (creatinine > 1.9 mg/dL).
Has significant hepatic disease, as indicated by clinical laboratory assessment (results ≥ 2 times the upper limit of normal for any liver function test (LFT), including aspartate aminotransferase (AST), alanine aminotransferase (ALT), and lactate dehydrogenase (LDH)).
Has a known history of seizure disorder, a family history of seizures, or previous head trauma.
Has loss of sensation in extremities or significant peripheral neuropathy.
Laboratory evidence of infection with HIV, positive test for HBsAg, or positive serology for hepatitis C virus (HCV) with positive test for HCV RNA.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lotus Clinical Research, Huntington Hospital
Pasadena, California, 91105

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, and Systemic Exposure of a Single Administration of FX301 Via Nerve Block for Management of Post-surgical Pain Following Bunionectomy

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy.

Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa.

Read the detailed description

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy.

Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy. At each step, the amount of FX301 administered (dose level) will be constant (65 mg, 130 mg, and 260 mg) so that the local safety of the drug loads and the volumes administered can be assessed separately. The 130 mg dose step will consist of both the low drug load at high volume and the high drug load at low volume concentrations.

A Safety Monitoring Committee (SMC) will review all safety data of each dose step prior to escalation to the next dose level.

After completion of the last cohort, data will be reviewed to assess whether to expand one of the four dose/volume cohorts up to and including the highest tolerated drug load/volume.

Conditions: Pain, Postoperative, Bunion
Being tested: FX301, Normal Saline
Medical subject headings: Pain, Postoperative, Bunion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FX301Drug
Also called funapide
FX301 is an extended-release formulation of funapide being developed as a single injection peripheral nerve block for the management of acute postsurgical pain
Normal SalineDrug
Single peripheral nerve injection

Study groups in NCT04826328
Study group	Role	What they receive
FX301 Low Dose Low Volume	Experimental	65 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa Receives: Drug: FX301
FX301 Low Dose High Volume	Experimental	130 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa Receives: Drug: FX301
FX301 High Dose Low Volume	Experimental	130 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa Receives: Drug: FX301
FX301 High Dose High Volume	Experimental	260 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa Receives: Drug: FX301
Normal Saline	Placebo comparator	Low or high matching volume of preservative-free normal saline given as a single injection adjacent to the sciatic nerve of the popliteal fossa Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of treatment emergent adverse events after FX301 is administered as a single-dose, analgesic nerve block
Incidence of treatment emergent adverse events after a single analgesic nerve block of FX301
Measured: Baseline to Day 85

Secondary outcomes (2)

Efficacy of FX301 in the management of acute post-surgical pain
Sum of pain intensity as measured by Numeric Rating Scale (NRS) from 0 to 10, 0 being no pain and 10 being the worst pain imaginable
Measured: Baseline to 72 Hours
Characterization of the systemic exposure of funapide as seen through the pharmacokinetic (PK) analysis at Days 1-6, 8, 15, 29, 57, and 85.
Measure of the concentration of funapide in blood plasma and urine
Measured: Baseline to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202130 Mar 2022

First posted1 Apr 2021
Study start15 Mar 2021
Primary completion11 Jan 2022
Study completion30 Mar 2022

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Part I - Double-Blind, placebo-controlled, three-step, Single Ascending Dose Part II - Double Blind, placebo-controlled, Expansion Phase to enroll additional patients to an SMC-cleared dose/volume level
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04826328
Sponsor's protocol ID: FX301-2020-001
Status last verified: Aug 2022
First submitted: 29 Mar 2021
Last updated: 26 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section

All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, and Systemic Exposure of a Single Administration of FX301 Via Nerve Block for Management of Post-surgical Pain Following Bunionectomy
ClinicalTrials.gov ID: NCT04826328
Acronym / sponsor ID: FX301-2020-001
Conditions: Pain, Postoperative, Bunion
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Collaborators: Lotus Clinical Research, LLC
Study start: 15 Mar 2021 (actual)
Primary completion: 11 Jan 2022 (actual)
Study completion: 30 Mar 2022 (actual)
First posted: 1 Apr 2021 (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.

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy.

Detailed description

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy.

A Safety Monitoring Committee (SMC) will review all safety data of each dose step prior to escalation to the next dose level.

After completion of the last cohort, data will be reviewed to assess whether to expand one of the four dose/volume cohorts up to and including the highest tolerated drug load/volume.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5
Model description: Part I - Double-Blind, placebo-controlled, three-step, Single Ascending Dose Part II - Double Blind, placebo-controlled, Expansion Phase to enroll additional patients to an SMC-cleared dose/volume level

Arm	Type	Receives
FX301 Low Dose Low Volume	Experimental	Drug: FX30165 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa
FX301 Low Dose High Volume	Experimental	Drug: FX301130 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa
FX301 High Dose Low Volume	Experimental	Drug: FX301130 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa
FX301 High Dose High Volume	Experimental	Drug: FX301260 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa
Normal Saline	Placebo comparator	Drug: Normal SalineLow or high matching volume of preservative-free normal saline given as a single injection adjacent to the sciatic nerve of the popliteal fossa

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Written consent to participate in the study
Be willing and able to complete study procedures and pain scales, follow instructions and communicate meaningfully in English with study personnel, and return for outpatient follow-up visits as required.
Male or female ≥18 to ≤65 years of age, inclusive
Planning to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation, without collateral procedure or additional surgeries, to be performed under Monitored Anesthesia Care (MAC) and be eligible to receive a popliteal sciatic nerve block
Classified as either ASA 1 or ASA 2 by the American Society of Anesthesiologists Physical Status Classification System (Appendix 1).

Key exclusion criteria (23 listed)

Has a concurrent painful condition, other than bunion-related pain, that may require analgesic treatment during the study period or may confound post-surgical pain assessments.
Has an active skin disease or other clinically significant abnormality at the anticipated site of surgery or nerve block insertion site that could interfere with the planned surgery.
Has had previous bunionectomy or other surgical procedure on the index foot that could impact the current bunion surgery.
Has any clinically significant cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the investigator, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any NSAIDs; history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to any other drugs used in the study, including anesthetics and antibiotics that may be required on the day of surgery.

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
FX301Also: funapideFX301 is an extended-release formulation of funapide being developed as a single injection peripheral nerve block for the management of acute postsurgical pain	Drug	FX301 High Dose High Volume, FX301 High Dose Low Volume, FX301 Low Dose High Volume, FX301 Low Dose Low Volume
Normal SalineSingle peripheral nerve injection	Drug	Normal Saline

Primary outcome

Incidence of treatment emergent adverse events after FX301 is administered as a single-dose, analgesic nerve block
Time frame: Baseline to Day 85
Incidence of treatment emergent adverse events after a single analgesic nerve block of FX301

2 secondary outcomes

Efficacy of FX301 in the management of acute post-surgical pain
Time frame: Baseline to 72 Hours
Characterization of the systemic exposure of funapide as seen through the pharmacokinetic (PK) analysis at Days 1-6, 8, 15, 29, 57, and 85.
Time frame: Baseline to Day 85

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 26 Aug 2022.

Related trials for Pain, Postoperative

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section

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.

William T Andrews, MD, FACP study director

Pacira Pharmaceuticals, Inc

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 FX301 and Normal Saline in people with Pain, Postoperative and Bunion, run by Pacira Pharmaceuticals, Inc 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 15 inclusion and 23 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 26 Aug 2022. 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?

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?

Incidence of treatment emergent adverse events after FX301 is administered as a single-dose, analgesic nerve block (time frame: Baseline to Day 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04826328.

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 26 Aug 2022.