<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/NCT04503629</url>
  </required_header>
  <id_info>
    <org_study_id>3571-DU-2001</org_study_id>
    <nct_id>NCT04503629</nct_id>
  </id_info>
  <brief_title>A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.</brief_title>
  <official_title>A Phase 2,Double-blinded, Double Dummy, Positive Drug, Parallel, Randomised Controlled Multicenter Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sihuan Pharmaceutical Holdings Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sihuan Pharmaceutical Holdings Group Ltd.</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>
      A phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled&#xD;
      multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD,&#xD;
      40mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2018</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</primary_completion_date>
  <phase>Phase 2</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>The endoscopic healing rate of duodenal ulcers at week 4.</measure>
    <time_frame>Treatment of 4 weeks</time_frame>
    <description>The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed evaluated by investigators.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Duodenal Ulcer，DU</condition>
  <arm_group>
    <arm_group_label>Anaprazole Sodium 20mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered orally once every 30-60 minutes before breakfast for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anaprazole Sodium 40mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered orally once every 30-60 minutes before breakfast for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rabeprazole sodium 10mg QD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>administered orally once every 30-60 minutes before breakfast for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anaprazole Sodium</intervention_name>
    <description>Anaprazole Sodium 20mg</description>
    <arm_group_label>Anaprazole Sodium 20mg QD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anaprazole Sodium</intervention_name>
    <description>Anaprazole Sodium 40mg</description>
    <arm_group_label>Anaprazole Sodium 40mg QD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rabeprazole sodium</intervention_name>
    <description>Rabeprazole sodium 10mg</description>
    <arm_group_label>Rabeprazole sodium 10mg QD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years, male and female&#xD;
&#xD;
          2. Has endoscopic diagnosis of active duodenal ulcer(s) (A1 or A2 stage) within 7 days&#xD;
             prior to randomization&#xD;
&#xD;
          3. 1 or 2 ulcers, 3-15 mm in diameter.&#xD;
&#xD;
          4. Signed informed concent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has malignancy ulcer or malignancy ulcer not excluded, compouned ulcer, stress ulcer,&#xD;
             esophageal erosion and ulcer, reflux esophagitis, Zollinger-Ellison syndrome.&#xD;
&#xD;
          2. Has esophageal and gastric varices；&#xD;
&#xD;
          3. With severe compliaction, such as pyloric obstruction, bleeding (Forrest I, IIa and&#xD;
             IIb) or perforation, and etc；&#xD;
&#xD;
          4. Has other gastrointestinal disease (e.g.gastric ulcer), or has history of inflammatory&#xD;
             bowel disease (such as Crohn's disease or ulcerative colitis)；&#xD;
&#xD;
          5. Has undergone surgical resection or partly resection of esophageal, stomach or&#xD;
             duodenum；&#xD;
&#xD;
          6. Has used Proton Pump Inhibitors(PPIs) within 5 days prior to randomization, or&#xD;
             continuous more than 3 days of use of Proton Pump Inhibitors within 2 weeks prior to&#xD;
             randomization；&#xD;
&#xD;
          7. Has been treated with triple or quandruple Helicobacter pylori eradication therapy&#xD;
             included PPIs within 28 days prior to randomization；&#xD;
&#xD;
          8. Current use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory&#xD;
             drugs, or anticoagulation drugs) which may induce ulcer or ulceric bleeding or&#xD;
             continuous more than 3 days of use the drugs (such as systemic glucocorticoids, non&#xD;
             steroid anti-inflammatory drugs, or anticoagulation drugs) within 28 days prior to&#xD;
             randomization；&#xD;
&#xD;
          9. Laboratory tests performed in screning stage revealed Alanine aminotransferase (ALT)&#xD;
             or aspartate aminotransferase (AST): &gt; 1.5 upper limit of normal (ULN);&#xD;
&#xD;
         10. Laboratory tests performed in screning stage revealed thyroid stimulating hormone&#xD;
             (TSH)；&#xD;
&#xD;
         11. Woman in pregnancy or lactation period；&#xD;
&#xD;
         12. Plan for pregancy or not willing to contracept with reliable contraception method&#xD;
             during study period and within 90 days after the final time of investigational drug&#xD;
             administratio；&#xD;
&#xD;
         13. Have alcohol abuse or drug abuse 1 years prior to screening；&#xD;
&#xD;
         14. Has hypersensitivity or allergy to investigatory drug, comparatory drug or related&#xD;
             supplements；&#xD;
&#xD;
         15. Has participated or been participating other clinical trials(non-interventional study&#xD;
             is excluded)；&#xD;
&#xD;
         16. Has an uncotroled disease, such as has a history of significant central nervous system&#xD;
             (CNS), cardiovascular, pulmonary, hepatic, renal, or mental or psychological disorders&#xD;
             with drug treatment that,in the opinion of the investigator, would not be suitable for&#xD;
             participating this clinical trial.&#xD;
&#xD;
         17. In the opinion of the investigator, the patients with other situation would not be&#xD;
             suitable for participating this clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Fisrst Affiliated Hospital of NanChang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</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>Duodenal Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabeprazole</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/NCT04503629
org study id: 3571-DU-2001
nct id: NCT04503629
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled
      multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD,
      40mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The endoscopic healing rate of duodenal ulcers at week 4.
time frame: Treatment of 4 weeks
description: The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed evaluated by investigators.
arm group label: Anaprazole Sodium 20mg QD
arm group type: Experimental
description: administered orally once every 30-60 minutes before breakfast for 4 weeks
arm group label: Anaprazole Sodium 40mg QD
arm group type: Experimental
description: administered orally once every 30-60 minutes before breakfast for 4 weeks
arm group label: Rabeprazole sodium 10mg QD
arm group type: Active Comparator
description: administered orally once every 30-60 minutes before breakfast for 4 weeks
intervention type: Drug
intervention name: Anaprazole Sodium
description: Anaprazole Sodium 20mg
arm group label: Anaprazole Sodium 20mg QD
intervention type: Drug
intervention name: Anaprazole Sodium
description: Anaprazole Sodium 40mg
arm group label: Anaprazole Sodium 40mg QD
intervention type: Drug
intervention name: Rabeprazole sodium
description: Rabeprazole sodium 10mg
arm group label: Rabeprazole sodium 10mg QD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Duodenal Ulcer
mesh term: Ulcer
mesh term: Rabeprazole