<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/NCT02194088</url>
  </required_header>
  <id_info>
    <org_study_id>2013P001857</org_study_id>
    <nct_id>NCT02194088</nct_id>
  </id_info>
  <brief_title>Combined Medication for Improved Analgesia in Superficial Pain</brief_title>
  <official_title>Potential for Improved Analgesia From Combined Medication for Superficial Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is being done to assess if a combination of medications can enhance the&#xD;
      relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The&#xD;
      investigators also want to find out if certain genes may be linked to individual differences&#xD;
      in experienced efficacy of pain killers. The combination of medications under investigation&#xD;
      is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug&#xD;
      Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain&#xD;
      types of poisoning, heartbeat problems, and other diseases but atropine is not approved to&#xD;
      treat pain. However, atropine has been used for many years in different European countries to&#xD;
      treat painful conditions such as stomach cramps.This research study will compare diclofenac&#xD;
      and atropine to placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Scores on Standardized Experimental Pain Testing</measure>
    <time_frame>baseline and 1 hour pain measurement</time_frame>
    <description>Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief</measure>
    <time_frame>baseline and 1 hour pain measurement</time_frame>
    <description>Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>baseline and 1 hour pain measurement</time_frame>
    <description>The investigators aimed assess if these would be a reason for discontinuation of treatment in a population with mild to moderate pain.Side effects will be assessed with a dichotomous measurement (yes/no)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Pain medication: diclofenac and atropine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules will be delivered in same number as the medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac and Atropine combination drug</intervention_name>
    <description>Diclofenac will be associated with a small dose of atropine 1.2mg</description>
    <arm_group_label>Pain medication: diclofenac and atropine</arm_group_label>
    <other_name>Analgesic drug</other_name>
    <other_name>Combination drug</other_name>
    <other_name>Test drug</other_name>
    <other_name>Diclofenac and atropine</other_name>
    <other_name>Atropine and diclofenac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>For each capsule of active medication, a capsule of placebo will be provided, identical looking.</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Placebo control for the active medication</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female healthy volunteers.&#xD;
&#xD;
          -  18-40 years of age.&#xD;
&#xD;
          -  Ability to read and understand English; English can be a second language provided that&#xD;
             the participant feels that he/she understand all the questions used in the assessment&#xD;
             measures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain condition or chronic or current treatment with any pain medication.&#xD;
&#xD;
          -  Presence of any illness or medication use that is judged to interfere with the trial.&#xD;
             For example: psychiatric disorder, medication that can influence cognition or&#xD;
             emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or&#xD;
             opioids.&#xD;
&#xD;
          -  Unwillingness to receive brief pain stimulation administered by a heat probe on the&#xD;
             hand.&#xD;
&#xD;
          -  Allergy or contra-indication to receiving nonsteroidal anti-inflammatory medication&#xD;
             and atropine (Treatment with antidepressants, neuroleptics, antihistaminic, levodopa,&#xD;
             anti-acids. Pregnancy, breast-feeding, myasthenia gravis, pyloric stenosis,&#xD;
             gastro-esophageal reflux, gastric ulcer, constipation, prostatic enlargement,&#xD;
             glaucoma, cardio-pulmonary condition -including tachycardia, arrhythmia,&#xD;
             arteriosclerosis-, hyperthyroidism, high blood pressure, genetic disease, kidney&#xD;
             failure)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert R Edwards, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham And Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Berna C, Kirsch I, Zion SR, Lee YC, Jensen KB, Sadler P, Kaptchuk TJ, Edwards RR. Side effects can enhance treatment response through expectancy effects: an experimental analgesic randomized controlled trial. Pain. 2017 Jun;158(6):1014-1020. doi: 10.1097/j.pain.0000000000000870.</citation>
    <PMID>28178072</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 11, 2013</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <results_first_submitted>November 1, 2016</results_first_submitted>
  <results_first_submitted_qc>April 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 30, 2017</results_first_posted>
  <last_update_submitted>June 4, 2018</last_update_submitted>
  <last_update_submitted_qc>June 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Robert Edwards</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Atropine</mesh_term>
    <mesh_term>Analgesics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pain Medication: Diclofenac and Atropine</title>
          <description>Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose&#xD;
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo capsules will be delivered in same number as the medication&#xD;
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pain Medication: Diclofenac and Atropine</title>
          <description>Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose&#xD;
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo capsules will be delivered in same number as the medication&#xD;
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.04" spread="4.75"/>
                    <measurement group_id="B2" value="23.16" spread="3.94"/>
                    <measurement group_id="B3" value="23.82" spread="4.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Scores on Standardized Experimental Pain Testing</title>
        <description>Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)</description>
        <time_frame>baseline and 1 hour pain measurement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pain Medication: Diclofenac and Atropine</title>
            <description>Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose&#xD;
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules will be delivered in same number as the medication&#xD;
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores on Standardized Experimental Pain Testing</title>
          <description>Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.6" spread="13.9"/>
                    <measurement group_id="O2" value="54.0" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour Assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.1" spread="22.7"/>
                    <measurement group_id="O2" value="45.3" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief</title>
        <description>Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism</description>
        <time_frame>baseline and 1 hour pain measurement</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Medication:Diclofenac an Atropine</title>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
          </group>
        </group_list>
        <measure>
          <title>Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief</title>
          <description>Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Side Effects</title>
        <description>The investigators aimed assess if these would be a reason for discontinuation of treatment in a population with mild to moderate pain.Side effects will be assessed with a dichotomous measurement (yes/no)</description>
        <time_frame>baseline and 1 hour pain measurement</time_frame>
        <population>Participants were analyzed in terms of whether they endorsed or not the side effects (yes/no) Participants were not analyzed in terms of severity degree</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Medication: Diclofenac and Atropine</title>
            <description>Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose&#xD;
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules will be delivered in same number as the medication&#xD;
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking.</description>
          </group>
        </group_list>
        <measure>
          <title>Side Effects</title>
          <description>The investigators aimed assess if these would be a reason for discontinuation of treatment in a population with mild to moderate pain.Side effects will be assessed with a dichotomous measurement (yes/no)</description>
          <population>Participants were analyzed in terms of whether they endorsed or not the side effects (yes/no) Participants were not analyzed in terms of severity degree</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Dry mouth</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other Side Effects</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No side effects</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pain Medication: Diclofenac and Atropine</title>
          <description>Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose&#xD;
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo capsules will be delivered in same number as the medication&#xD;
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Edwards Robert</name_or_title>
      <organization>Brigham and Women's Hospital</organization>
      <phone>617-732-9486</phone>
      <email>rredwards@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02194088
org study id: 2013P001857
nct id: NCT02194088
lead sponsor: 
collaborator: 
has dmc: No
This research study is being done to assess if a combination of medications can enhance the
      relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The
      investigators also want to find out if certain genes may be linked to individual differences
      in experienced efficacy of pain killers. The combination of medications under investigation
      is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug
      Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain
      types of poisoning, heartbeat problems, and other diseases but atropine is not approved to
      treat pain. However, atropine has been used for many years in different European countries to
      treat painful conditions such as stomach cramps.This research study will compare diclofenac
      and atropine to placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Scores on Standardized Experimental Pain Testing
time frame: baseline and 1 hour pain measurement
description: Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)
measure: Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief
time frame: baseline and 1 hour pain measurement
description: Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism
measure: Side Effects
time frame: baseline and 1 hour pain measurement
description: The investigators aimed assess if these would be a reason for discontinuation of treatment in a population with mild to moderate pain.Side effects will be assessed with a dichotomous measurement (yes/no)
arm group label: Pain medication: diclofenac and atropine
arm group type: Experimental
description: Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo capsules will be delivered in same number as the medication
intervention type: Drug
intervention name: Diclofenac and Atropine combination drug
description: Diclofenac will be associated with a small dose of atropine 1.2mg
arm group label: Pain medication: diclofenac and atropine
other name: Analgesic drug
other name: Combination drug
other name: Test drug
other name: Diclofenac and atropine
other name: Atropine and diclofenac
intervention type: Drug
intervention name: Placebo
description: For each capsule of active medication, a capsule of placebo will be provided, identical looking.
arm group label: placebo
other name: Placebo control for the active medication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert R Edwards, PHD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
citation: Berna C, Kirsch I, Zion SR, Lee YC, Jensen KB, Sadler P, Kaptchuk TJ, Edwards RR. Side effects can enhance treatment response through expectancy effects: an experimental analgesic randomized controlled trial. Pain. 2017 Jun;158(6):1014-1020. doi: 10.1097/j.pain.0000000000000870.
PMID: 28178072
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Robert Edwards
investigator title: Professor
mesh term: Diclofenac
mesh term: Atropine
mesh term: Analgesics
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 