<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/NCT03029845</url>
  </required_header>
  <id_info>
    <org_study_id>00084875</org_study_id>
    <nct_id>NCT03029845</nct_id>
  </id_info>
  <brief_title>Propranolol for Treating Fibromyalgia Pain</brief_title>
  <official_title>Propranolol for Treating Fibromyalgia Pain: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study to evaluate the feasibility of using low dose propranolol for people&#xD;
      with fibromyalgia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this study is to collect pilot feasibility study data for the use of low&#xD;
      dose propranolol for helping treat fibromyalgia. The investigators plan to compare 20mg twice&#xD;
      a day dosage of propranolol and 10mg twice a day dosage of propranolol to placebo. The design&#xD;
      is a 3 arm, double blind randomized control trial. The investigators will also test ECG and&#xD;
      respiratory assessment as a part of the safety screening and the feasible assessment of&#xD;
      respiratory sinus arrhythmia.&#xD;
&#xD;
      Propranolol is not indicated to treat pain. However, the previous studies showed that low&#xD;
      dose propranolol can re-regulate the adrenergic dysfunction and reduce pain in people with&#xD;
      chronic musculoskeletal pain. However, the investigators are not aiming to develop a new&#xD;
      indication of the drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The funding ended.&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>Phase 1</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>Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)</measure>
    <time_frame>Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)</time_frame>
    <description>Changes in clinical pain will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue</measure>
    <time_frame>Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)</time_frame>
    <description>Changes in fibromyalgia-related symptoms</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Fibromyalgia Pain</condition>
  <arm_group>
    <arm_group_label>propranolol 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 mg propranolol twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>propranolol 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg propranolol twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propranolol 1</intervention_name>
    <description>Participants will take 20 mg propranolol twice a day for 2 weeks</description>
    <arm_group_label>propranolol 1</arm_group_label>
    <other_name>20 mg propranolol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propranolol 2</intervention_name>
    <description>Participants will take 10 mg propranolol twice a day for 2 weeks</description>
    <arm_group_label>propranolol 2</arm_group_label>
    <other_name>10 mg propranolol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will take placebo twice a day for 2 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females with fibromyalgia (both meeting 1990 American College of Rheumatology (ACR)&#xD;
             FMS criteria and 2010 ACR FMS criteria) age 18-65 with at least 1 year of symptoms and&#xD;
             sedentary (exercising less than 120 min per week).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General Health Criteria:&#xD;
&#xD;
               -  Uncontrolled/unstable illnesses (physician diagnosed, self-report)&#xD;
&#xD;
               -  Pregnancy or planning to be pregnant in the next year&#xD;
&#xD;
               -  Having Asthma requiring medication treatment including inhaler&#xD;
&#xD;
               -  Type I diabetes or Type II diabetes requiring medical therapy that can lead to&#xD;
                  hypoglycemia&#xD;
&#xD;
               -  Having acute pain or neuropathic pain&#xD;
&#xD;
               -  Participation in exercise or psychological treatment studies in the past 2 years&#xD;
&#xD;
               -  Having known serious psychopathology: Psychosis, history of inpatient psychiatric&#xD;
                  admission in the past year, active suicidal intent, history of self-injurious&#xD;
                  behaviors in the past year, history of recreational IV drug use, substance abuse&#xD;
                  history in the past year)&#xD;
&#xD;
          -  Cardiovascular Criteria:&#xD;
&#xD;
               -  Having known cardiovascular diseases (self-report, physician diagnosed)&#xD;
&#xD;
               -  Pacemaker&#xD;
&#xD;
               -  Bradycardia (resting heartrate of less than 55 bpm)&#xD;
&#xD;
               -  Resting diastolic BP &lt; 55 mmHG or systolic BP&lt;100 mmHG&#xD;
&#xD;
               -  ECG showing prolonged PR interval &gt; .2 sec&#xD;
&#xD;
               -  ECG showing irregular PR interval&#xD;
&#xD;
               -  ECG showing incongruence between P wave and QRS&#xD;
&#xD;
          -  Medication Criteria&#xD;
&#xD;
               -  Allergy or intolerance of beta blockers&#xD;
&#xD;
               -  Current use of the following drugs:&#xD;
&#xD;
                    -  Antihypertensive drugs&#xD;
&#xD;
                    -  Neuroleptics&#xD;
&#xD;
                    -  Monoamine oxidase inhibitors&#xD;
&#xD;
                    -  Tizanidine&#xD;
&#xD;
                    -  Amphetamine-based medications&#xD;
&#xD;
                    -  Bupropion&#xD;
&#xD;
                    -  Mirtazapine&#xD;
&#xD;
                    -  Tricyclics: daily dose greater than 75mg amitriptyline or equivalent&#xD;
&#xD;
                    -  Benzodiazepine: daily dose greater than 5mg diazepam or equivalent&#xD;
&#xD;
                    -  Asthmatic medicine, including inhaler&#xD;
&#xD;
               -  Participants may be included after minimum of 4 weeks of physician prescribed&#xD;
                  termination of these drugs&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akiko Okifuji, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2018</last_update_submitted>
  <last_update_submitted_qc>August 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Akiko Okifuji</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propranolol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03029845
org study id: 00084875
nct id: NCT03029845
lead sponsor: 
has dmc: Yes
The purpose of the study to evaluate the feasibility of using low dose propranolol for people
      with fibromyalgia.
The main purpose of this study is to collect pilot feasibility study data for the use of low
      dose propranolol for helping treat fibromyalgia. The investigators plan to compare 20mg twice
      a day dosage of propranolol and 10mg twice a day dosage of propranolol to placebo. The design
      is a 3 arm, double blind randomized control trial. The investigators will also test ECG and
      respiratory assessment as a part of the safety screening and the feasible assessment of
      respiratory sinus arrhythmia.

      Propranolol is not indicated to treat pain. However, the previous studies showed that low
      dose propranolol can re-regulate the adrenergic dysfunction and reduce pain in people with
      chronic musculoskeletal pain. However, the investigators are not aiming to develop a new
      indication of the drug.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
time frame: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
description: Changes in clinical pain will be measured
measure: Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue
time frame: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
description: Changes in fibromyalgia-related symptoms
arm group label: propranolol 1
arm group type: Active Comparator
description: 20 mg propranolol twice a day
arm group label: propranolol 2
arm group type: Active Comparator
description: 10 mg propranolol twice a day
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo twice a day
intervention type: Drug
intervention name: Propranolol 1
description: Participants will take 20 mg propranolol twice a day for 2 weeks
arm group label: propranolol 1
other name: 20 mg propranolol
intervention type: Drug
intervention name: Propranolol 2
description: Participants will take 10 mg propranolol twice a day for 2 weeks
arm group label: propranolol 2
other name: 10 mg propranolol
intervention type: Drug
intervention name: Placebo
description: Participants will take placebo twice a day for 2 weeks
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Akiko Okifuji, PhD
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Akiko Okifuji
investigator title: Professor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Propranolol
sharing ipd: No