<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/NCT03806205</url>
  </required_header>
  <id_info>
    <org_study_id>PekingUPHmed</org_study_id>
    <nct_id>NCT03806205</nct_id>
  </id_info>
  <brief_title>Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain</brief_title>
  <official_title>Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effect of dichloride on pain control of knee osteoarthritis and the&#xD;
      relationship between pain relief and medicine adherence. To evaluate the pain relief rate of&#xD;
      patients with different initial pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 15, 2019</start_date>
  <completion_date type="Anticipated">March 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 10, 2019</primary_completion_date>
  <phase>N/A</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>adherence</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>We will calculate adherence with medication use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain relief rate</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>We will calculate the pain relief rate on all participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>womac score</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>We will calculate the womac score on all participants</description>
  </secondary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>regular follow-up</intervention_name>
    <description>we give a regular follow-up and supervision on the study group</description>
    <other_name>supervision</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  According to the OA diagnostic criteria of knee joint, the side with higher WOMAC&#xD;
             score is defined as observing knee joint for patients with both knees conforming to OA&#xD;
             diagnostic criteria.&#xD;
&#xD;
               1. Repeated knee pain in the past month&#xD;
&#xD;
               2. X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic&#xD;
                  degeneration, and formation of osteophyte at articular margin.&#xD;
&#xD;
               3. Joint fluid (&gt; 2 times) is cool and sticky, WBC &lt; 2000/ml&#xD;
&#xD;
               4. Age over 40&#xD;
&#xD;
               5. Morning stiffness less than 30 minutes&#xD;
&#xD;
               6. Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or&#xD;
                  1+4+5+6, OA of knee joint can be diagnosed.&#xD;
&#xD;
               7. The informed consent has been signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2)&#xD;
             Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe&#xD;
             internal medical complications and other inability to participate in the research (4)&#xD;
             Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active&#xD;
             peptic ulcer/allergy/induced asthma (6) Assessment may not complete the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianhao Lin, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yudian Qiu, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yudian Qiu, M.D.</last_name>
    <phone>+8613381150519</phone>
    <email>1210301417@pku.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jianhao Lin, M.D.</last_name>
    <email>linjianhao@pkuph.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Xicheng District</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yudian Qiu, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>da Costa BR, Reichenbach S, Keller N, Nartey L, Wandel S, Juni P, Trelle S. RETRACTED: Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis. Lancet. 2016 May 21;387(10033):2093-2105. doi: 10.1016/S0140-6736(16)30002-2. Epub 2016 Mar 18.</citation>
    <PMID>26997557</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee osteoarthritis pain; Adherence; Diclofenac; Follow up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03806205
org study id: PekingUPHmed
nct id: NCT03806205
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate the effect of dichloride on pain control of knee osteoarthritis and the
      relationship between pain relief and medicine adherence. To evaluate the pain relief rate of
      patients with different initial pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: adherence
time frame: 6-8 weeks
description: We will calculate adherence with medication use
measure: pain relief rate
time frame: 6-8 weeks
description: We will calculate the pain relief rate on all participants
measure: womac score
time frame: 6-8 weeks
description: We will calculate the womac score on all participants
intervention type: Other
intervention name: regular follow-up
description: we give a regular follow-up and supervision on the study group
other name: supervision
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Jianhao Lin, M.D.
role: Study Chair
affiliation: Peking University People's Hospital
last name: Yudian Qiu, M.D.
role: Study Director
affiliation: Peking University People's Hospital
last name: Yudian Qiu, M.D.
phone: +8613381150519
email: 1210301417@pku.edu.cn
last name: Jianhao Lin, M.D.
email: linjianhao@pkuph.edu.cn
facility: 
contact: 
country: China
citation: da Costa BR, Reichenbach S, Keller N, Nartey L, Wandel S, Juni P, Trelle S. RETRACTED: Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis. Lancet. 2016 May 21;387(10033):2093-2105. doi: 10.1016/S0140-6736(16)30002-2. Epub 2016 Mar 18.
PMID: 26997557
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided