<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03838133</url>
  </required_header>
  <id_info>
    <org_study_id>TLC590A1002</org_study_id>
    <nct_id>NCT03838133</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taiwan Liposome Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taiwan Liposome Company</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study&#xD;
      to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local&#xD;
      administration in adult subjects following bunionectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study&#xD;
      to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local&#xD;
      administration in adult subjects following bunionectomy.&#xD;
&#xD;
      The primary objective of this study is to evaluate the analgesic efficacy of TLC590 for&#xD;
      post-surgical pain management in subjects following bunionectomy.&#xD;
&#xD;
      The secondary objectives of this study are:&#xD;
&#xD;
        -  To evaluate the pharmacokinetic (PK) profile and dose-exposure relationship of TLC590,&#xD;
           as well as the bioavailability as compared with Naropin®.&#xD;
&#xD;
        -  To evaluate the safety and tolerability of TLC590 for post-surgical pain management in&#xD;
           subjects following bunionectomy.&#xD;
&#xD;
        -  To evaluate the exposure-response relationship between PK parameters and pain intensity.&#xD;
&#xD;
      The study will be divided into two parts:&#xD;
&#xD;
      Part 1: Blinded Pharmacokinetics of TLC590 and Naropin®. Approximately 48 subjects will be&#xD;
      randomized to treatments.&#xD;
&#xD;
      Part 2: Efficacy and Safety of TLC590 versus bupivacaine and Placebo. Part 2 of the study&#xD;
      will randomize approximately 150 evaluable subjects who meet all entry criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC of numerical pain rating scale</measure>
    <time_frame>0-24 hours, 0-72 hours</time_frame>
    <description>AUC of numerical pain rating scale (NPRS-R) following bunionectomy surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK Cmax</measure>
    <time_frame>0-168 hours</time_frame>
    <description>Maximum blood concentration (Cmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Tmax</measure>
    <time_frame>0-168 hours</time_frame>
    <description>Time to reach maximum blood concentration (Tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK t½</measure>
    <time_frame>0-168 hours</time_frame>
    <description>Terminal elimination half-life (t½)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK AUC</measure>
    <time_frame>0-24, 0-48 , 0-72, 0-96 hours</time_frame>
    <description>Area under the blood concentration-time curve (AUC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of treatment emergent adverse event (TEAE)</measure>
    <time_frame>Screening through Day 43</time_frame>
    <description>Number of treatment emergent adverse event (TEAE) occurred in the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiogram (RR interval, QRS duration, QT duration, PR duration, QTcF interval)</measure>
    <time_frame>Screening through Day 43</time_frame>
    <description>The 12-lead electrocardiogram (ECG) result will be assessed including RR interval, QRS duration, QT duration, PR duration, and QTcF interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound assessment by Numerical Pain Rating Scale (NPRS)</measure>
    <time_frame>Day 1 through Day 43</time_frame>
    <description>The surgical site will be examined by the investigator using a 5-point numerical pain rating scale as follows:&#xD;
Normal healing&#xD;
Bruising, erythema, edema&#xD;
Clear or hemoserous drainage&#xD;
Evidence of cellulitis such as heat, spreading erythema, purulent discharge&#xD;
Tissue breakdown, wound dehiscence, hematoma requiring aspiration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of NPRS-R (0-10)</measure>
    <time_frame>0-36, 0-48, 0-72, 0-96, 0-120,24-48, 48-72, 72-96, 96-120, and 120-168 hours</time_frame>
    <description>AUC of NPRS-R (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of pain-free (NPRS-R of 0 or 1) subjects</measure>
    <time_frame>at 12, 24, 36, 48, 72, 96, 120, and 168 hours</time_frame>
    <description>Proportion of pain-free (NPRS-R of 0 or 1) subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who used no rescue opioid analgesic</measure>
    <time_frame>through 12, 24, 36, 48, 72, 96, 120, and 168 hours</time_frame>
    <description>Proportion of subjects who used no rescue opioid analgesic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to the first postoperative use of rescue opioid analgesics</measure>
    <time_frame>Day 1 to Day 43</time_frame>
    <description>Time to the first postoperative use of rescue opioid analgesics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total postoperative consumption of rescue opioid analgesics used</measure>
    <time_frame>through 24, 36, 48, 60, 72, 96, 120, and 168 hours</time_frame>
    <description>Total postoperative consumption of rescue opioid analgesics used</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Hallux Valgus</condition>
  <arm_group>
    <arm_group_label>TLC590 dose 1 (152 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TLC590 dose 2 (190 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TLC590 dose 3 (228 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Naropin®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Naronpin injection contains ropivacaine HCl 50 mg (0.5%, 10 mL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal Saline (0.9% sodium chloride, 10 mL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine HCl 50 mg (0.5%, 10 mL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TLC590</intervention_name>
    <description>TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients</description>
    <arm_group_label>TLC590 dose 1 (152 mg)</arm_group_label>
    <arm_group_label>TLC590 dose 2 (190 mg)</arm_group_label>
    <arm_group_label>TLC590 dose 3 (228 mg)</arm_group_label>
    <other_name>TLC590 (Ropivacaine Liposome Injectable Suspension)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naropin®</intervention_name>
    <description>Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)</description>
    <arm_group_label>Naropin®</arm_group_label>
    <other_name>Naropin, 0.5% Injectable Solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Normal Saline (0.9% sodium chloride, 10ml)</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Bupivacaine 50 mg (0.5%, 10 mL)</description>
    <arm_group_label>Bupivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able and willing to provide a written informed consent.&#xD;
&#xD;
          2. Male or female between 18 and 65 years of age.&#xD;
&#xD;
          3. Body mass index ≤ 35 kg/m2.&#xD;
&#xD;
          4. Mild to moderate hallux valgus deformity.&#xD;
&#xD;
          5. Scheduled to undergo a primary, unilateral first metatarsal bunionectomy repair under&#xD;
             local anesthesia.&#xD;
&#xD;
          6. American Society of Anesthesiology Physical Status Classification of 1 or 2 at&#xD;
             screening.&#xD;
&#xD;
          7. Female subjects are eligible only if all of the following apply:&#xD;
&#xD;
               -  Not pregnant;&#xD;
&#xD;
               -  Not lactating;&#xD;
&#xD;
               -  Not planning to become pregnant during the study;&#xD;
&#xD;
               -  Commits to the use of an acceptable form of birth control for the duration of the&#xD;
                  study and for 42 days from administration of study drug.&#xD;
&#xD;
          8. Male subjects must be surgically sterile (biologically or surgically) or commit to the&#xD;
             use of a reliable method of birth control, for the duration of the study until at&#xD;
             least 1 week after the administration of study medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant abnormal clinical laboratory test value.&#xD;
&#xD;
          2. Evidence of a clinically significant 12-lead ECG abnormality.&#xD;
&#xD;
          3. History or evidence of orthostatic hypotension, syncope or other syncopal attacks.&#xD;
&#xD;
          4. History or clinical manifestations of significant renal, hepatic, gastrointestinal,&#xD;
             cardiovascular, metabolic, neurologic, psychiatric, or other condition that would&#xD;
             preclude participation in the study.&#xD;
&#xD;
          5. A history of seizure disorder or currently taking anticonvulsants.&#xD;
&#xD;
          6. History of hypersensitivity to ropivacaine, any other amide-type local anesthetic,&#xD;
             propofol, lidocaine, midazolam, acetaminophen, naproxen, morphine or oxycodone (or&#xD;
             other opioids).&#xD;
&#xD;
          7. Concurrent painful physical condition that may confound post-operative pain&#xD;
             assessments.&#xD;
&#xD;
          8. Persistent or recurrent nausea and/or vomiting due to other etiologies.&#xD;
&#xD;
          9. History of severe or refractory post-operative nausea or vomiting (PONV) deemed&#xD;
             clinically significant.&#xD;
&#xD;
         10. History of alcohol abuse or prescription/illicit drug abuse within 2 years.&#xD;
&#xD;
         11. Current evidence of alcohol abuse within 6 months.&#xD;
&#xD;
         12. Received opioid therapy for longer than 4 days per week within 2 months or opioid use&#xD;
             within 2 weeks.&#xD;
&#xD;
         13. Use of concurrent therapy that could interfere with the evaluation of efficacy or&#xD;
             safety.&#xD;
&#xD;
         14. Unable to discontinue medications that have not been at a stable dose for at least 14&#xD;
             days prior to the study surgical procedure, within 5 half-lives of the specific prior&#xD;
             medication.&#xD;
&#xD;
         15. Use of any of the following medications within 5 half-lives or as specified prior to&#xD;
             the study surgical procedure:&#xD;
&#xD;
               -  Low-dose aspirin therapy for cardiovascular protection&#xD;
&#xD;
               -  Class III antiarrhythmic drugs&#xD;
&#xD;
               -  Strong CYP1A2 inhibitors&#xD;
&#xD;
               -  CYP1A2 substrates&#xD;
&#xD;
               -  Strong CYP3A4 inhibitors&#xD;
&#xD;
               -  Corticosteroids, either systemically, inhaled either intranasally or orally, or&#xD;
                  by intra-articular injection, or NSAIDs within 14 days&#xD;
&#xD;
               -  Any investigational product within 30 days.&#xD;
&#xD;
         16. Positive results on the urine drug screen or alcohol breath test indicative of illicit&#xD;
             drug or alcohol abuse.&#xD;
&#xD;
         17. History or positive test results for HIV; active Hepatitis B or C.&#xD;
&#xD;
         18. Contralateral foot bunionectomy in the last 3 months or have collateral procedures.&#xD;
&#xD;
         19. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or&#xD;
             squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.&#xD;
&#xD;
         20. History of rheumatoid disease, Type 1 or Type 2 diabetes or peripheral circulatory&#xD;
             disorders.&#xD;
&#xD;
         21. Documented sleep apnea or are on home continuous positive airway pressure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl Brown, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Taiwan Liposome Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials, LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Research Group</name>
      <address>
        <city>Pasadena</city>
        <state>Maryland</state>
        <zip>21122-1020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endeavor Clinical Trials</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JBR clinical research</name>
      <address>
        <city>Draper</city>
        <state>Utah</state>
        <zip>84020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 24, 2021</submitted>
    <returned>December 23, 2021</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03838133
org study id: TLC590A1002
nct id: NCT03838133
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study
      to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local
      administration in adult subjects following bunionectomy.
This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study
      to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local
      administration in adult subjects following bunionectomy.

      The primary objective of this study is to evaluate the analgesic efficacy of TLC590 for
      post-surgical pain management in subjects following bunionectomy.

      The secondary objectives of this study are:

        -  To evaluate the pharmacokinetic (PK) profile and dose-exposure relationship of TLC590,
           as well as the bioavailability as compared with Naropin®.

        -  To evaluate the safety and tolerability of TLC590 for post-surgical pain management in
           subjects following bunionectomy.

        -  To evaluate the exposure-response relationship between PK parameters and pain intensity.

      The study will be divided into two parts:

      Part 1: Blinded Pharmacokinetics of TLC590 and Naropin®. Approximately 48 subjects will be
      randomized to treatments.

      Part 2: Efficacy and Safety of TLC590 versus bupivacaine and Placebo. Part 2 of the study
      will randomize approximately 150 evaluable subjects who meet all entry criteria.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: AUC of numerical pain rating scale
time frame: 0-24 hours, 0-72 hours
description: AUC of numerical pain rating scale (NPRS-R) following bunionectomy surgery
measure: PK Cmax
time frame: 0-168 hours
description: Maximum blood concentration (Cmax)
measure: PK Tmax
time frame: 0-168 hours
description: Time to reach maximum blood concentration (Tmax)
measure: PK t½
time frame: 0-168 hours
description: Terminal elimination half-life (t½)
measure: PK AUC
time frame: 0-24, 0-48 , 0-72, 0-96 hours
description: Area under the blood concentration-time curve (AUC)
measure: Number of treatment emergent adverse event (TEAE)
time frame: Screening through Day 43
description: Number of treatment emergent adverse event (TEAE) occurred in the study
measure: Electrocardiogram (RR interval, QRS duration, QT duration, PR duration, QTcF interval)
time frame: Screening through Day 43
description: The 12-lead electrocardiogram (ECG) result will be assessed including RR interval, QRS duration, QT duration, PR duration, and QTcF interval
measure: Wound assessment by Numerical Pain Rating Scale (NPRS)
time frame: Day 1 through Day 43
description: The surgical site will be examined by the investigator using a 5-point numerical pain rating scale as follows:
Normal healing
Bruising, erythema, edema
Clear or hemoserous drainage
Evidence of cellulitis such as heat, spreading erythema, purulent discharge
Tissue breakdown, wound dehiscence, hematoma requiring aspiration
measure: AUC of NPRS-R (0-10)
time frame: 0-36, 0-48, 0-72, 0-96, 0-120,24-48, 48-72, 72-96, 96-120, and 120-168 hours
description: AUC of NPRS-R (0-10)
measure: Proportion of pain-free (NPRS-R of 0 or 1) subjects
time frame: at 12, 24, 36, 48, 72, 96, 120, and 168 hours
description: Proportion of pain-free (NPRS-R of 0 or 1) subjects
measure: Proportion of subjects who used no rescue opioid analgesic
time frame: through 12, 24, 36, 48, 72, 96, 120, and 168 hours
description: Proportion of subjects who used no rescue opioid analgesic
measure: Time to the first postoperative use of rescue opioid analgesics
time frame: Day 1 to Day 43
description: Time to the first postoperative use of rescue opioid analgesics
measure: Total postoperative consumption of rescue opioid analgesics used
time frame: through 24, 36, 48, 60, 72, 96, 120, and 168 hours
description: Total postoperative consumption of rescue opioid analgesics used
arm group label: TLC590 dose 1 (152 mg)
arm group type: Experimental
description: TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
arm group label: TLC590 dose 2 (190 mg)
arm group type: Experimental
description: TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
arm group label: TLC590 dose 3 (228 mg)
arm group type: Experimental
description: TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
arm group label: Naropin®
arm group type: Active Comparator
description: Naronpin injection contains ropivacaine HCl 50 mg (0.5%, 10 mL)
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal Saline (0.9% sodium chloride, 10 mL)
arm group label: Bupivacaine
arm group type: Active Comparator
description: Bupivacaine HCl 50 mg (0.5%, 10 mL)
intervention type: Drug
intervention name: TLC590
description: TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients
arm group label: TLC590 dose 1 (152 mg)
arm group label: TLC590 dose 2 (190 mg)
arm group label: TLC590 dose 3 (228 mg)
other name: TLC590 (Ropivacaine Liposome Injectable Suspension)
intervention type: Drug
intervention name: Naropin®
description: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)
arm group label: Naropin®
other name: Naropin, 0.5% Injectable Solution
intervention type: Drug
intervention name: Normal Saline
description: Normal Saline (0.9% sodium chloride, 10ml)
arm group label: Placebo
other name: Saline
intervention type: Drug
intervention name: Bupivacaine
description: Bupivacaine 50 mg (0.5%, 10 mL)
arm group label: Bupivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Carl Brown, PhD
role: Study Director
affiliation: Taiwan Liposome Company
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hallux Valgus
mesh term: Pain, Postoperative
mesh term: Bupivacaine
mesh term: Ropivacaine
sharing ipd: No
submitted: November 24, 2021
returned: December 23, 2021