<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/NCT03794310</url>
  </required_header>
  <id_info>
    <org_study_id>NPF-08-01/C-01</org_study_id>
    <nct_id>NCT03794310</nct_id>
  </id_info>
  <brief_title>Study of NPF-08 in Patients Who Receive Colonoscopy</brief_title>
  <official_title>A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nihon Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nihon Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</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>
      To study non-inferiority of intestinal cleansing effect in both NPF-08 1-day treatment group&#xD;
      and NPF-08 2-day split dose group to the cleansing effect in Moviprep® 1-day treatment group,&#xD;
      for the subjects who will receive endoscopy large bowel. If the non-inferiority will be&#xD;
      validated, superiority of intestinal cleansing effect in both groups of NPF-08 will be&#xD;
      studied.&#xD;
&#xD;
      Furthermore, for the assessment of safety of NPF-08, the adverse events and adverse drug&#xD;
      reactions observed after the administration to post-examination period will be studied,&#xD;
      compared to those at Moviprep® 1-day treatment group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2019</start_date>
  <completion_date type="Actual">June 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 19, 2019</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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC).</measure>
    <time_frame>1day</time_frame>
    <description>The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is &quot;1&quot; or &quot;2&quot; at all colon segments, it is judged as effective. Other cases will be judged as not effective.&#xD;
Almost no residue is found in the intestinal tract enabling good observation&#xD;
Residue remains but does not interfere the observation&#xD;
Residue interferes the observation&#xD;
A lot of residue makes unable to observe&#xD;
Unable to evaluate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The efficacy rate of overall intestinal cleansing effect evaluated by colonoscopists</measure>
    <time_frame>1day</time_frame>
    <description>The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is &quot;1&quot; or &quot;2&quot; at all colon segments, it is judged as effective. Other cases will be judged as not effective.&#xD;
Almost no residue is found in the intestinal tract enabling good observation&#xD;
Residue remains but does not interfere the observation&#xD;
Residue interferes the observation&#xD;
A lot of residue makes unable to observe&#xD;
Unable to evaluate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colon cleansing effect by site</measure>
    <time_frame>1day</time_frame>
    <description>The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated.&#xD;
Almost no residue is found in the intestinal tract enabling good observation&#xD;
Residue remains but does not interfere the observation&#xD;
Residue interferes the observation&#xD;
A lot of residue makes unable to observe&#xD;
Unable to evaluate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation based on Ottawa Bowel Preparation Scale</measure>
    <time_frame>1day</time_frame>
    <description>Endoscopic operators will evaluate for colon cleansing degree at the bowel 5 sites (cecum/ascending colon, transverse colon, descending colon, sigmoid colon and rectum) based on the following 5 degrees (0-4) and the amount of fluid at overall bowel based on the following 3 degrees (0-2), and will also evaluate the status during operating normal endoscopy. Lower score indicates better cleansing effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy.</measure>
    <time_frame>1day</time_frame>
    <description>Clinical cooperator will determine the duration from the initiation of administration of the investigational product on the day of colonoscopy to the time when the cooperator will decide that colon cleansing will be completed as the discharged liquid will become transparent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage of the investigational product.</measure>
    <time_frame>1day or 2day</time_frame>
    <description>Clinical cooperator will determine the dosage of the investigational product from the initiation of administration of the investigational product to the time when the cooperator will decide that colon cleansing will be completed as the discharged liquid will become transparent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance rate of intestinal cleansing effect between by EIEC members.</measure>
    <time_frame>1day</time_frame>
    <description>For the evaluations of intestinal cleansing degree conducted at the primary endpoint, the concordance rate between by 3 members of EIEC will be investigated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance rate between the intestinal cleansing effect evaluated by EIEC and the endoscopic operators.</measure>
    <time_frame>1day</time_frame>
    <description>For the evaluations of intestinal cleansing degree conducted at the primary endpoint and secondary endpoints, the concordance rate between the evaluations by EIEC and that by the endoscopic operators will be investigated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability by subjects</measure>
    <time_frame>1day</time_frame>
    <description>Subjects will evaluate the following points by selecting among 10 levels (circling the applicable figure): Taste of the investigational product; amount of the investigational product; amount of water you will drink after taking the investigational product; and acceptability of the pre-medication (will you choose the pre-medication at the next time?).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">632</enrollment>
  <condition>Patients Who Receive Colonoscopy</condition>
  <arm_group>
    <arm_group_label>NPF-08 （1-day treatment）</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NPF-08 （2-day split dose）</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Moviprep（1-day treatment）</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPF-08 （1-day treatment）</intervention_name>
    <description>NPF-08 will be administered on the day of colonoscopy.</description>
    <arm_group_label>NPF-08 （1-day treatment）</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPF-08 （2-day split dose）</intervention_name>
    <description>NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.</description>
    <arm_group_label>NPF-08 （2-day split dose）</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moviprep（1-day treatment）</intervention_name>
    <description>Moviprep will be administered on the day of colonoscopy.</description>
    <arm_group_label>Moviprep（1-day treatment）</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Japanese men and women aged 20 years or older at obtaining the written informed&#xD;
             consent.&#xD;
&#xD;
          2. Patients who require colonoscopy (except for emergency colonoscopy)&#xD;
&#xD;
          3. Patients who have the ability to consent and submit the written informed consent by&#xD;
             themselves.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have or are suspected to have gastrointestinal obstruction.&#xD;
&#xD;
          2. Patients who have or are suspected to have intestinal perforation.&#xD;
&#xD;
          3. Patients who have or are suspected to have toxic megacolon.&#xD;
&#xD;
          4. Patients who have or are suspected to have gastric evacuation disorder&#xD;
             (gastroparesis).&#xD;
&#xD;
          5. Patients with intestinal stenosis or high-grade constipation (stool frequency of 2 or&#xD;
             less in a week or who have used laxative on a daily basis).&#xD;
&#xD;
          6. Patients with vomiting reflex or in whom accidental ingestion may occur.&#xD;
&#xD;
          7. Patients with a history of gastrointestinal surgery (except for appendicectomy).&#xD;
&#xD;
          8. Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.&#xD;
&#xD;
          9. Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL&#xD;
             or more)&#xD;
&#xD;
         10. Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or&#xD;
             more or AST: 100IU/L or more)&#xD;
&#xD;
         11. Patients who have undergone or require therapy due to high-grade cardiac disease&#xD;
             (including angina pectoris or myocardial infarction)&#xD;
&#xD;
         12. Patients with high risk of arrhythmia (with a history or complications of QT&#xD;
             prolongation, myocardial infarction, angina pectoris, cardiac failure or&#xD;
             cardiomyopathy)&#xD;
&#xD;
         13. Patients with dehydration.&#xD;
&#xD;
         14. Patients who were diagnosed with active inflammatory bowel disease at screening&#xD;
             period.&#xD;
&#xD;
         15. Inpatients due to the reasons other than endoscopy large bowel.&#xD;
&#xD;
         16. Patients who have undergone nutritional control using total parenteral nutrition or&#xD;
             enteral nutrition.&#xD;
&#xD;
         17. Women who are or may be pregnant, lactating or wish to become pregnant during the&#xD;
             trial period.&#xD;
&#xD;
         18. Patients with a history or high-risk of seizure.&#xD;
&#xD;
         19. Patients with a history of shock or hypersensitivity for the active ingredient of the&#xD;
             investigational product.&#xD;
&#xD;
         20. Patients who have received the other investigational product within 4 months before&#xD;
             the written informed consent or who are participating in the other clinical trials.&#xD;
&#xD;
         21. Patients in whom Investigator/Sub-Investigator decided not to be eligible for this&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hisatsugu Asada</last_name>
    <role>Study Chair</role>
    <affiliation>Nihon Pharmaceutical Co., Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NPF-08 Trial Site 12</name>
      <address>
        <city>Abiko</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 11</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 1</name>
      <address>
        <city>Maebashi</city>
        <state>Gunnma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 10</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 5</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 9</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 2</name>
      <address>
        <city>Chuo-Ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 3</name>
      <address>
        <city>Minato-Ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 4</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 8</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 13</name>
      <address>
        <city>Kouchi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 6</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPF-08 Trial Site 7</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>November 27, 2022</last_update_submitted>
  <last_update_submitted_qc>November 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03794310
org study id: NPF-08-01/C-01
nct id: NCT03794310
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study non-inferiority of intestinal cleansing effect in both NPF-08 1-day treatment group
      and NPF-08 2-day split dose group to the cleansing effect in Moviprep® 1-day treatment group,
      for the subjects who will receive endoscopy large bowel. If the non-inferiority will be
      validated, superiority of intestinal cleansing effect in both groups of NPF-08 will be
      studied.

      Furthermore, for the assessment of safety of NPF-08, the adverse events and adverse drug
      reactions observed after the administration to post-examination period will be studied,
      compared to those at Moviprep® 1-day treatment group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC).
time frame: 1day
description: The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is "1" or "2" at all colon segments, it is judged as effective. Other cases will be judged as not effective.
Almost no residue is found in the intestinal tract enabling good observation
Residue remains but does not interfere the observation
Residue interferes the observation
A lot of residue makes unable to observe
Unable to evaluate
measure: The efficacy rate of overall intestinal cleansing effect evaluated by colonoscopists
time frame: 1day
description: The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is "1" or "2" at all colon segments, it is judged as effective. Other cases will be judged as not effective.
Almost no residue is found in the intestinal tract enabling good observation
Residue remains but does not interfere the observation
Residue interferes the observation
A lot of residue makes unable to observe
Unable to evaluate
measure: Colon cleansing effect by site
time frame: 1day
description: The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated.
Almost no residue is found in the intestinal tract enabling good observation
Residue remains but does not interfere the observation
Residue interferes the observation
A lot of residue makes unable to observe
Unable to evaluate
measure: Evaluation based on Ottawa Bowel Preparation Scale
time frame: 1day
description: Endoscopic operators will evaluate for colon cleansing degree at the bowel 5 sites (cecum/ascending colon, transverse colon, descending colon, sigmoid colon and rectum) based on the following 5 degrees (0-4) and the amount of fluid at overall bowel based on the following 3 degrees (0-2), and will also evaluate the status during operating normal endoscopy. Lower score indicates better cleansing effect.
measure: Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy.
time frame: 1day
description: Clinical cooperator will determine the duration from the initiation of administration of the investigational product on the day of colonoscopy to the time when the cooperator will decide that colon cleansing will be completed as the discharged liquid will become transparent.
measure: Dosage of the investigational product.
time frame: 1day or 2day
description: Clinical cooperator will determine the dosage of the investigational product from the initiation of administration of the investigational product to the time when the cooperator will decide that colon cleansing will be completed as the discharged liquid will become transparent.
measure: Concordance rate of intestinal cleansing effect between by EIEC members.
time frame: 1day
description: For the evaluations of intestinal cleansing degree conducted at the primary endpoint, the concordance rate between by 3 members of EIEC will be investigated.
measure: Concordance rate between the intestinal cleansing effect evaluated by EIEC and the endoscopic operators.
time frame: 1day
description: For the evaluations of intestinal cleansing degree conducted at the primary endpoint and secondary endpoints, the concordance rate between the evaluations by EIEC and that by the endoscopic operators will be investigated.
measure: Acceptability by subjects
time frame: 1day
description: Subjects will evaluate the following points by selecting among 10 levels (circling the applicable figure): Taste of the investigational product; amount of the investigational product; amount of water you will drink after taking the investigational product; and acceptability of the pre-medication (will you choose the pre-medication at the next time?).
arm group label: NPF-08 （1-day treatment）
arm group type: Experimental
arm group label: NPF-08 （2-day split dose）
arm group type: Experimental
arm group label: Moviprep（1-day treatment）
arm group type: Active Comparator
intervention type: Drug
intervention name: NPF-08 （1-day treatment）
description: NPF-08 will be administered on the day of colonoscopy.
arm group label: NPF-08 （1-day treatment）
intervention type: Drug
intervention name: NPF-08 （2-day split dose）
description: NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.
arm group label: NPF-08 （2-day split dose）
intervention type: Drug
intervention name: Moviprep（1-day treatment）
description: Moviprep will be administered on the day of colonoscopy.
arm group label: Moviprep（1-day treatment）
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hisatsugu Asada
role: Study Chair
affiliation: Nihon Pharmaceutical Co., Ltd
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor