<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/NCT03800797</url>
  </required_header>
  <id_info>
    <org_study_id>[2014]2-135</org_study_id>
    <nct_id>NCT03800797</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis</brief_title>
  <official_title>Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus&#xD;
      loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial&#xD;
      includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day)&#xD;
      or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 4-week randomized, open-label trial to investigate the efficacy and safety of&#xD;
      loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients&#xD;
      with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly&#xD;
      assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for&#xD;
      4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2015</start_date>
  <completion_date type="Actual">December 10, 2015</completion_date>
  <primary_completion_date type="Actual">December 10, 2015</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)</measure>
    <time_frame>week 4</time_frame>
    <description>ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ASAS5/6 response</measure>
    <time_frame>week 4</time_frame>
    <description>defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASAS20 response</measure>
    <time_frame>week 2</time_frame>
    <description>ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASAS5/6 response</measure>
    <time_frame>week 2</time_frame>
    <description>defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>LX-P group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LX-T group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loxoprofen sodium hydrogel patch</intervention_name>
    <description>100 mg per day</description>
    <arm_group_label>LX-P group</arm_group_label>
    <other_name>Loxoprofen hydrogel patch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loxoprofen sodium tablet</intervention_name>
    <description>60 mg t.i.d.</description>
    <arm_group_label>LX-T group</arm_group_label>
    <other_name>Loxoprofen tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 65 years&#xD;
&#xD;
          -  Meet 1984 modified New York criteria for AS&#xD;
&#xD;
          -  The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the&#xD;
             Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level&#xD;
             (ASDAS-CRP) ≥1.3&#xD;
&#xD;
          -  NSAIDs washout period of at least 5 days prior to randomization&#xD;
&#xD;
          -  DMARDs washout period of at least 4 weeks prior to randomization&#xD;
&#xD;
          -  Corticosteroids washout period of at least 4 weeks prior to randomization&#xD;
&#xD;
          -  Biological agents washout period of at least 3 months prior to randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Peptic ulcer&#xD;
&#xD;
          -  Unstable cardiac diseases&#xD;
&#xD;
          -  Abnormal hepatic function with an elevation of alanine aminotransferase (ALT) or&#xD;
             aspartate aminotransferase (AST) ≥ 2.5 times of upper normal limits&#xD;
&#xD;
          -  Abnormal renal function with creatinine more than upper normal limit&#xD;
&#xD;
          -  Hematologic disorders&#xD;
&#xD;
          -  Psychosis&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Allergic to LX drug.&#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>Jieruo Gu, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Gu Jieruo</investigator_full_name>
    <investigator_title>Director, Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-Sen University</investigator_title>
  </responsible_party>
  <keyword>ankylosing spondylitis</keyword>
  <keyword>loxoprofen</keyword>
  <keyword>patch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loxoprofen</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03800797
org study id: [2014]2-135
nct id: NCT03800797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus
      loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial
      includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day)
      or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.
This is a 4-week randomized, open-label trial to investigate the efficacy and safety of
      loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients
      with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly
      assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for
      4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)
time frame: week 4
description: ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
measure: ASAS5/6 response
time frame: week 4
description: defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
measure: ASAS20 response
time frame: week 2
description: ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
measure: ASAS5/6 response
time frame: week 2
description: defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
arm group label: LX-P group
arm group type: Experimental
description: loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks
arm group label: LX-T group
arm group type: Active Comparator
description: loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks
intervention type: Drug
intervention name: Loxoprofen sodium hydrogel patch
description: 100 mg per day
arm group label: LX-P group
other name: Loxoprofen hydrogel patch
intervention type: Drug
intervention name: Loxoprofen sodium tablet
description: 60 mg t.i.d.
arm group label: LX-T group
other name: Loxoprofen tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jieruo Gu, Prof
role: Study Director
affiliation: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Gu Jieruo
investigator title: Director, Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-Sen University
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Loxoprofen