<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/NCT01696734</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0261</org_study_id>
    <secondary_id>NCI-2012-02093</secondary_id>
    <secondary_id>2012-0261</secondary_id>
    <nct_id>NCT01696734</nct_id>
  </id_info>
  <brief_title>Domperidone in Treating Patients With Gastrointestinal Disorders</brief_title>
  <official_title>Treatment Protocol for the Compassionate Use of Domperidone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial studies how well domperidone works in treating patients with&#xD;
      gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders&#xD;
      and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating&#xD;
      contraction of the stomach to increase its ability to empty itself of food.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To provide treatment with domperidone to patients &gt;= 16 years of age where, according to&#xD;
      the investigators' judgment, a prokinetic effect is needed for the relief of gastrointestinal&#xD;
      (GI) motility disorders.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive domperidone orally (PO) thrice daily (TID) or four times daily (QID).&#xD;
      Treatment continues in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for at least 30 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 23, 2012</start_date>
  <completion_date type="Anticipated">October 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Scale ranges from &quot;0&quot; meaning &quot;None&quot; to &quot;5&quot; meaning &quot;Very Severe&quot;.&#xD;
Patients will be classified as either &quot;new&quot; or &quot;continuing&quot; at the baseline visit. A new patient will have a &quot;response&quot; if he/she has a 25% reduction in GCSI at 8 weeks. A continuing patient will already have early benefit to treatment so will have a &quot;response&quot; if the GCSI score does not increase more than 20% over baseline at 8 weeks. Summary statistics including number (n), mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in patients' self-report of symptoms</measure>
    <time_frame>Baseline to 30 days after completion of study treatment</time_frame>
    <description>Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0</measure>
    <time_frame>Up to 30 days after completion of study treatment</time_frame>
    <description>Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed. Patient adverse events will be tabulated by symptom, grade, and relationship to study drug.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Digestive System Disorder</condition>
  <condition>Dyspepsia</condition>
  <condition>Esophagitis</condition>
  <condition>Gastroesophageal Reflux Disease</condition>
  <condition>Gastroparesis</condition>
  <condition>Heartburn</condition>
  <condition>Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Treatment (domperidone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Domperidone</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (domperidone)</arm_group_label>
    <other_name>KW 5338</other_name>
    <other_name>Motilium</other_name>
    <other_name>R 33,812</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (domperidone)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with GI disorders who have failed standard therapy&#xD;
&#xD;
          -  Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux&#xD;
             disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related&#xD;
             laryngitis, and respiratory symptoms; or c) severe dyspepsia&#xD;
&#xD;
          -  Completion of a comprehensive evaluation, including clinical history and physical&#xD;
             examination, to eliminate other causes of their symptoms&#xD;
&#xD;
          -  Patient has signed the informed consent document agreeing to the use of the study&#xD;
             drug, domperidone&#xD;
&#xD;
          -  White blood cell (WBC) with differential greater than 3,000/ml&#xD;
&#xD;
          -  Alkaline phosphatase less than 1.5 x upper limit of normal&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) less than 2 x upper limit of normal&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) less than 2 x upper limit of normal&#xD;
&#xD;
          -  Bilirubin less than or equal to 2 x upper limit of normal&#xD;
&#xD;
          -  Blood urea nitrogen (BUN) less than 2 x upper limit of normal&#xD;
&#xD;
          -  Creatinine less than 1.5 x upper limit of normal&#xD;
&#xD;
          -  Stable hemoglobin greater than or equal to 8.0 g/dl&#xD;
&#xD;
          -  Potassium between range of 3.0 to 5.5&#xD;
&#xD;
          -  Magnesium level between 1.6-2.6 mg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with the following cardiac diagnoses: ventricular tachycardia or&#xD;
             fibrillation; Torsade des Pointes; clinically significant bradycardia; sinus node&#xD;
             dysfunction; heart block; prolonged QTc interval (QTc &gt; 450 milliseconds for males,&#xD;
             QTc &gt; 470 milliseconds for females); prior specific cardiovascular conditions of&#xD;
             clinically significant valvular heart disease requiring medication, ischemic, or&#xD;
             pulmonary heart disease; cardiomyopathy; history of heart failure&#xD;
&#xD;
          -  Patients who are receiving antiarrhythmic medications with action on repolarization&#xD;
             times (with prolongation of the QTc interval such as amiodarone, disopyramide,&#xD;
             dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)&#xD;
&#xD;
          -  Patients who are receiving monoamine oxidase (MAO) inhibitors&#xD;
&#xD;
          -  Patients with a history of or active liver failure&#xD;
&#xD;
          -  Clinically significant electrolyte disorders including sodium &lt; 130 or &gt; 145 and/or&#xD;
             potassium &lt; 3.0 or &gt; 5.5 and/or magnesium &lt; 1.6 or &gt; 2.6&#xD;
&#xD;
          -  GI hemorrhage or obstruction experienced within the previous 6 weeks&#xD;
&#xD;
          -  Presence of a prolactinoma (prolactin-releasing pituitary tumor)&#xD;
&#xD;
          -  Pregnant or breast-feeding female (women of childbearing potential [WOCBP], defined as&#xD;
             not post-menopausal for 12 months or without previous surgical sterilization, must&#xD;
             have a negative urine pregnancy test within 30 days of the first administration of&#xD;
             domperidone and must either commit to continued abstinence from heterosexual&#xD;
             intercourse or use an effective method of birth control during the course of the&#xD;
             study)&#xD;
&#xD;
          -  Known allergy to domperidone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehnaz Shafi</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mehnaz Shafi</last_name>
    <phone>713-794-5073</phone>
    <email>mashafi@mdanderson.orgs</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mehnaz Shafi</last_name>
      <phone>713-794-5073</phone>
    </contact>
    <investigator>
      <last_name>Mehnaz Shafi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis</mesh_term>
    <mesh_term>Gastroparesis</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
    <mesh_term>Heartburn</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Domperidone</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/NCT01696734
org study id: 2012-0261
secondary id: NCI-2012-02093
secondary id: 2012-0261
nct id: NCT01696734
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase III trial studies how well domperidone works in treating patients with
      gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders
      and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating
      contraction of the stomach to increase its ability to empty itself of food.
PRIMARY OBJECTIVES:

      I. To provide treatment with domperidone to patients >= 16 years of age where, according to
      the investigators' judgment, a prokinetic effect is needed for the relief of gastrointestinal
      (GI) motility disorders.

      OUTLINE:

      Patients receive domperidone orally (PO) thrice daily (TID) or four times daily (QID).
      Treatment continues in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for at least 30 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
time frame: Baseline to 8 weeks
description: Scale ranges from "0" meaning "None" to "5" meaning "Very Severe".
Patients will be classified as either "new" or "continuing" at the baseline visit. A new patient will have a "response" if he/she has a 25% reduction in GCSI at 8 weeks. A continuing patient will already have early benefit to treatment so will have a "response" if the GCSI score does not increase more than 20% over baseline at 8 weeks. Summary statistics including number (n), mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
measure: Change in patients' self-report of symptoms
time frame: Baseline to 30 days after completion of study treatment
description: Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
measure: Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0
time frame: Up to 30 days after completion of study treatment
description: Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed. Patient adverse events will be tabulated by symptom, grade, and relationship to study drug.
arm group label: Treatment (domperidone)
arm group type: Experimental
description: Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Domperidone
description: Given PO
arm group label: Treatment (domperidone)
other name: KW 5338
other name: Motilium
other name: R 33,812
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Treatment (domperidone)
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Mehnaz Shafi
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Mehnaz Shafi
phone: 713-794-5073
email: mashafi@mdanderson.orgs
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis
mesh term: Gastroparesis
mesh term: Digestive System Diseases
mesh term: Gastrointestinal Diseases
mesh term: Vomiting
mesh term: Dyspepsia
mesh term: Heartburn
mesh term: Domperidone