<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/NCT04429282</url>
  </required_header>
  <id_info>
    <org_study_id>2017PHA019</org_study_id>
    <nct_id>NCT04429282</nct_id>
  </id_info>
  <brief_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yi Feng, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study was to evaluate the efficacy and safety of intravenously administered ibuprofen&#xD;
      400mg and 800 mg q6h for the management of moderate to severe postoperative pain in Chinese&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, parallel, double-blind, placebo controlled multi-center clinical study was&#xD;
      conducted in 396 patients scheduled to undergo elective general anesthesia laparotomy or&#xD;
      orthopedic surgery. Patients were randomly divided into three groups in radio 1:1:1 received&#xD;
      respectively IV placebo, ibuprofen 400 mg or ibuprofen 800 mg. The first dose of study drugs&#xD;
      was administered intravenously at the time of wound closure and then every 6 hours within 48&#xD;
      hours after the operation. At the end of surgical suture, 5mg morphine was injected&#xD;
      intravenously, and then the patient-controlled intravenous analgesia pump was connected.&#xD;
      Efficacy was assessed by morphine dosage during the first 24 hours, pain intensity score, and&#xD;
      area under the pain-time curve after surgery. Safety was assessed by the incidence of adverse&#xD;
      events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 10, 2020</start_date>
  <completion_date type="Anticipated">June 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2020</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the amount of morphine administered</measure>
    <time_frame>during the first 24 hours</time_frame>
    <description>after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity (PI)</measure>
    <time_frame>at 0 hour,1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours and 48 hours immediately after the first administration.</time_frame>
    <description>the PI was evaluated using patient self-reporting with numerical rating scales (NRS) (0= no pain to 10= intense pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The area under the PI-time curve (AUC)</measure>
    <time_frame>across 3 time periods (1-24 hours, 6-24 hours, 12-24 hours)</time_frame>
    <description>at rest and with movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total frequency and effective frequency of PCA</measure>
    <time_frame>within 24 hours</time_frame>
    <description>after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment failure rate</measure>
    <time_frame>within 24 hours after the operation</time_frame>
    <description>the rate of using other non-morphine drugs to remedy analgesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' evaluation of the study drug</measure>
    <time_frame>after 48 hours of medication</time_frame>
    <description>excellent=5, very good=4, good=3, general=2, bad=1</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">396</enrollment>
  <condition>Ibuprofen</condition>
  <condition>Nonsteroidal Anti-inflammatory Drug</condition>
  <condition>Intravenous</condition>
  <condition>Injectable</condition>
  <condition>Pain</condition>
  <condition>Analgesic</condition>
  <arm_group>
    <arm_group_label>ibuprofen( 400mg group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were randomly divided into the group received respectively IV ibuprofen 400 mg .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ibuprofen( 800mg group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were randomly divided into the group received respectively IV ibuprofen 800 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients were randomly divided into the group received respectively IV placebo,.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ibuprofen</intervention_name>
    <description>Patients were randomly divided into three groups in radio 1:1:1 received respectively IV placebo, ibuprofen 400 mg or ibuprofen 800 mg. The first dose of study drugs was administered intravenously at the time of wound closure and then every 6 hours within 48 hours after the operation.</description>
    <arm_group_label>ibuprofen( 400mg group)</arm_group_label>
    <arm_group_label>ibuprofen( 800mg group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrollment was open to patients undergoing scheduled abdominal surgery (intestinal or&#xD;
             lower abdomen) or orthopedic surgery (such as knee arthroplasty or shoulder joint&#xD;
             reconstruction) under general anesthesia with endotracheal intubation and were&#xD;
             expected to require patient-controlled intravenous analgesia (PCIA) pump for more than&#xD;
             24h for moderate to severe pain after surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who can not understand the NRS score and cooperate with the evaluation; those&#xD;
             who had head trauma or complicated with organic lesions of the central nervous system&#xD;
             within 4 weeks before operation; those who developed coagulation dysfunction or took&#xD;
             anticoagulants and antiplatelet drugs; those with a history of severe&#xD;
             cardio-cerebrovascular disease, heart failure; those with liver and kidney&#xD;
             dysfunction, severe endocrine system diseases, mental illness; those with a history of&#xD;
             peptic ulcer or bleeding; those who did not control grade 2 or above hypertension or&#xD;
             were still taking two or more of antihypertensive drugs such as angiotensin converting&#xD;
             enzyme inhibitors (ACEI), angiotensin converting enzyme antagonists (ARB) and&#xD;
             diuretics at admission; Increased toxicity due to the interaction of methotrexate,&#xD;
             lithium preparations, etc. with the test drug; use of NSAIDs or analgesic muscle&#xD;
             relaxants within 24 hours before operation, narcotic dependence or tolerance; allergy&#xD;
             to ibuprofen or other NSAIDs; pregnant or lactating women&#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>Yi Feng, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi Feng, MD</last_name>
    <phone>08601088325590</phone>
    <email>yifeng65@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Feng, MD</last_name>
      <phone>08601088325590</phone>
      <email>yifeng65@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Yi Feng, MD</investigator_full_name>
    <investigator_title>Director of department of anesthesiology and painmanagement</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</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/NCT04429282
org study id: 2017PHA019
nct id: NCT04429282
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was to evaluate the efficacy and safety of intravenously administered ibuprofen
      400mg and 800 mg q6h for the management of moderate to severe postoperative pain in Chinese
      population.
This randomized, parallel, double-blind, placebo controlled multi-center clinical study was
      conducted in 396 patients scheduled to undergo elective general anesthesia laparotomy or
      orthopedic surgery. Patients were randomly divided into three groups in radio 1:1:1 received
      respectively IV placebo, ibuprofen 400 mg or ibuprofen 800 mg. The first dose of study drugs
      was administered intravenously at the time of wound closure and then every 6 hours within 48
      hours after the operation. At the end of surgical suture, 5mg morphine was injected
      intravenously, and then the patient-controlled intravenous analgesia pump was connected.
      Efficacy was assessed by morphine dosage during the first 24 hours, pain intensity score, and
      area under the pain-time curve after surgery. Safety was assessed by the incidence of adverse
      events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: the amount of morphine administered
time frame: during the first 24 hours
description: after surgery.
measure: Pain intensity (PI)
time frame: at 0 hour,1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours and 48 hours immediately after the first administration.
description: the PI was evaluated using patient self-reporting with numerical rating scales (NRS) (0= no pain to 10= intense pain)
measure: The area under the PI-time curve (AUC)
time frame: across 3 time periods (1-24 hours, 6-24 hours, 12-24 hours)
description: at rest and with movement
measure: Total frequency and effective frequency of PCA
time frame: within 24 hours
description: after surgery
measure: Treatment failure rate
time frame: within 24 hours after the operation
description: the rate of using other non-morphine drugs to remedy analgesia
measure: Patients' evaluation of the study drug
time frame: after 48 hours of medication
description: excellent=5, very good=4, good=3, general=2, bad=1
arm group label: ibuprofen( 400mg group)
arm group type: Experimental
description: Patients were randomly divided into the group received respectively IV ibuprofen 400 mg .
arm group label: ibuprofen( 800mg group)
arm group type: Experimental
description: Patients were randomly divided into the group received respectively IV ibuprofen 800 mg.
arm group label: placebo group
arm group type: Placebo Comparator
description: Patients were randomly divided into the group received respectively IV placebo,.
intervention type: Drug
intervention name: ibuprofen
description: Patients were randomly divided into three groups in radio 1:1:1 received respectively IV placebo, ibuprofen 400 mg or ibuprofen 800 mg. The first dose of study drugs was administered intravenously at the time of wound closure and then every 6 hours within 48 hours after the operation.
arm group label: ibuprofen( 400mg group)
arm group label: ibuprofen( 800mg group)
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yi Feng, MD
role: Study Chair
affiliation: Peking University People's Hospital
last name: Yi Feng, MD
phone: 08601088325590
email: yifeng65@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Yi Feng, MD
investigator title: Director of department of anesthesiology and painmanagement
mesh term: Pain, Postoperative
mesh term: Ibuprofen