<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/NCT03305068</url>
  </required_header>
  <id_info>
    <org_study_id>BI177194</org_study_id>
    <nct_id>NCT03305068</nct_id>
  </id_info>
  <brief_title>Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery</brief_title>
  <official_title>Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis Joint Replacement Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis Joint Replacement Institute</source>
  <brief_summary>
    <textblock>
      Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex)&#xD;
      will experience significantly reduced narcotic use as measured by pill count compared with&#xD;
      controls at three and six weeks postoperatively.&#xD;
&#xD;
      Study Overview The proposed study will determine if there is benefit to the use of a COX-II&#xD;
      inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement,&#xD;
      both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms&#xD;
      are necessary because each surgery is distinct in terms of type of procedure, indications,&#xD;
      and patient population. The patients in Arm 1 will undergo stratified randomization according&#xD;
      to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these&#xD;
      patients within subgroups. All patients undergoing primary total shoulder replacement,&#xD;
      reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to&#xD;
      participate in the appropriate arm of the study. Revision surgery patients will be excluded&#xD;
      from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78&#xD;
      arthroplasty patients will be enrolled in each arm of the study. Baseline information will be&#xD;
      obtained on each patient including baseline VAS for pain, baseline shoulder scores as&#xD;
      outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients&#xD;
      will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or&#xD;
      placebo; they will then continue to receive the same medication daily for 3 weeks&#xD;
      postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome&#xD;
      measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome&#xD;
      measures will include subjective measure of pain as measured by the VAS for pain, range of&#xD;
      motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient&#xD;
      assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder&#xD;
      and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks&#xD;
      postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex)&#xD;
      will experience significantly reduced narcotic use as measured by pill count compared with&#xD;
      controls at three and six weeks postoperatively.&#xD;
&#xD;
      Study Overview The proposed study will determine if there is benefit to the use of a COX-II&#xD;
      inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement,&#xD;
      both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms&#xD;
      are necessary because each surgery is distinct in terms of type of procedure, indications,&#xD;
      and patient population. The patients in Arm 1 will undergo stratified randomization according&#xD;
      to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these&#xD;
      patients within subgroups. All patients undergoing primary total shoulder replacement,&#xD;
      reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to&#xD;
      participate in the appropriate arm of the study. Revision surgery patients will be excluded&#xD;
      from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78&#xD;
      arthroplasty patients will be enrolled in each arm of the study. Baseline information will be&#xD;
      obtained on each patient including baseline VAS for pain, baseline shoulder scores as&#xD;
      outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients&#xD;
      will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or&#xD;
      placebo; they will then continue to receive the same medication daily for 3 weeks&#xD;
      postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome&#xD;
      measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome&#xD;
      measures will include subjective measure of pain as measured by the VAS for pain, range of&#xD;
      motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient&#xD;
      assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder&#xD;
      and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks&#xD;
      postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption.</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption.</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Reverse or Primary Total Shoulder</condition>
  <condition>Rotator Cuff- Full Thickness- Repair</condition>
  <arm_group>
    <arm_group_label>the use of a COX-II inhibitor in shoulder surgery.</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm 1 shoulder replacement, both primary and reverse</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the use of a COX-II inhibitor in arhroscopic shoulder surgery.</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm 2 arthroscopic rotator cuff repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <arm_group_label>the use of a COX-II inhibitor in arhroscopic shoulder surgery.</arm_group_label>
    <arm_group_label>the use of a COX-II inhibitor in shoulder surgery.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion / Exclusion Criteria for Pfizer Study&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. community ambulators&#xD;
&#xD;
          2. D/C to home only&#xD;
&#xD;
          3. only MO and IL pts&#xD;
&#xD;
          4. Primary unilateral shoulder replacements / Cuff tear&#xD;
&#xD;
          5. Full Thickness, single tendon tear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. allergy, sensitivity, or inability to take Celebrex&#xD;
&#xD;
          2. CR &gt;1.5&#xD;
&#xD;
          3. h/o bleeding ulcers&#xD;
&#xD;
          4. h/o Inflammatory bowel disease, Crohn's disease, ulcerative colitis&#xD;
&#xD;
          5. Coagulation abnormality&#xD;
&#xD;
          6. Coumadin/Plavix/Xaralto&#xD;
&#xD;
          7. CHF&#xD;
&#xD;
          8. Previous MI or CVA&#xD;
&#xD;
          9. Current use of long acting narcotics (Fentanyl Patches, Oxycontin CR, MS Contin)&#xD;
&#xD;
         10. Refusal by PCP or cardiologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Burns, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SSM orthopedics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SSM DePaul</name>
      <address>
        <city>Bridgeton</city>
        <state>Missouri</state>
        <zip>63044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>February 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</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/NCT03305068
org study id: BI177194
nct id: NCT03305068
lead sponsor: 
Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex)
      will experience significantly reduced narcotic use as measured by pill count compared with
      controls at three and six weeks postoperatively.

      Study Overview The proposed study will determine if there is benefit to the use of a COX-II
      inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement,
      both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms
      are necessary because each surgery is distinct in terms of type of procedure, indications,
      and patient population. The patients in Arm 1 will undergo stratified randomization according
      to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these
      patients within subgroups. All patients undergoing primary total shoulder replacement,
      reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to
      participate in the appropriate arm of the study. Revision surgery patients will be excluded
      from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78
      arthroplasty patients will be enrolled in each arm of the study. Baseline information will be
      obtained on each patient including baseline VAS for pain, baseline shoulder scores as
      outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients
      will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or
      placebo; they will then continue to receive the same medication daily for 3 weeks
      postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome
      measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome
      measures will include subjective measure of pain as measured by the VAS for pain, range of
      motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient
      assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder
      and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks
      postoperatively.
Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex)
      will experience significantly reduced narcotic use as measured by pill count compared with
      controls at three and six weeks postoperatively.

      Study Overview The proposed study will determine if there is benefit to the use of a COX-II
      inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement,
      both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms
      are necessary because each surgery is distinct in terms of type of procedure, indications,
      and patient population. The patients in Arm 1 will undergo stratified randomization according
      to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these
      patients within subgroups. All patients undergoing primary total shoulder replacement,
      reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to
      participate in the appropriate arm of the study. Revision surgery patients will be excluded
      from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78
      arthroplasty patients will be enrolled in each arm of the study. Baseline information will be
      obtained on each patient including baseline VAS for pain, baseline shoulder scores as
      outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients
      will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or
      placebo; they will then continue to receive the same medication daily for 3 weeks
      postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome
      measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome
      measures will include subjective measure of pain as measured by the VAS for pain, range of
      motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient
      assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder
      and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks
      postoperatively.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption.
time frame: 3 weeks
measure: This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption.
time frame: 6 weeks
arm group label: the use of a COX-II inhibitor in shoulder surgery.
arm group type: Placebo Comparator
description: Arm 1 shoulder replacement, both primary and reverse
arm group label: the use of a COX-II inhibitor in arhroscopic shoulder surgery.
arm group type: Placebo Comparator
description: Arm 2 arthroscopic rotator cuff repair
intervention type: Drug
intervention name: Celecoxib
arm group label: the use of a COX-II inhibitor in arhroscopic shoulder surgery.
arm group label: the use of a COX-II inhibitor in shoulder surgery.
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Katherine Burns, MD
role: Principal Investigator
affiliation: SSM orthopedics
facility: 
country: United States
responsible party type: Sponsor
mesh term: Celecoxib