<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/NCT02261636</url>
  </required_header>
  <id_info>
    <org_study_id>000157</org_study_id>
    <nct_id>NCT02261636</nct_id>
  </id_info>
  <brief_title>Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment</brief_title>
  <acronym>IMPACT</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      For both induction of remission and in maintenance of remission, different doses and&#xD;
      treatment durations are used in practice. The aim of this study is to assess how mesalazine&#xD;
      is used in clinical practice, at which doses and for how long and how these differences&#xD;
      impact the patient disease state and work productivity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">January 14, 2019</completion_date>
  <primary_completion_date type="Actual">January 14, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to dose reduction</measure>
    <time_frame>From Day 1 up to one year</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Pentasa</arm_group_label>
    <description>Treatment according to standard clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mesalazine</intervention_name>
    <arm_group_label>Pentasa</arm_group_label>
    <other_name>Pentasa</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Out-patient clinics in the Netherlands&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with mild to moderate active ulcerative colitis with disease extension beyond&#xD;
             the rectum (≥ 10 cm) who will receive oral Pentasa treatment (Compact sachets and/or&#xD;
             tablets) for the treatment of the current active episode or in whom on oral Pentasa&#xD;
             maintenance treatment induction of remission treatment will be initiated by dose&#xD;
             escalation. Treatment combined with Pentasa enema (1g/100ml) is allowed.&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving treatment with one or more of the following: locally acting&#xD;
             steroids (e.g. budesonide, beclomethasone), systemic steroids, immunosuppressants&#xD;
             (e.g. thiopurines), biologicals (e.g. anti-Tumor Necrosis Factor-alpha)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Compliance</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gelre Ziekenhuizen (there may be other sites in this country)</name>
      <address>
        <city>Zutphen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <citation>West R, Russel M, Bodelier A, Kuijvenhoven J, Bruin K, Jansen J, Van der Meulen A, Keulen E, Wolters L, Ouwendijk R, Bezemer G, Koussoulas V, Tang T, Van Dobbenburgh A, Van Nistelrooy M, Minderhoud I, Vandebosch S, Lubbinge H. Lower Risk of Recurrence with a Higher Induction Dose of Mesalazine and Longer Duration of Treatment in Ulcerative Colitis: Results from the Dutch, Non-Interventional, IMPACT Study. J Gastrointestin Liver Dis. 2022 Mar 19;31(1):18-24. doi: 10.15403/jgld-3927.</citation>
    <PMID>35306553</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</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>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mesalamine</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/NCT02261636
org study id: 000157
nct id: NCT02261636
lead sponsor: 
For both induction of remission and in maintenance of remission, different doses and
      treatment durations are used in practice. The aim of this study is to assess how mesalazine
      is used in clinical practice, at which doses and for how long and how these differences
      impact the patient disease state and work productivity.
observational model: Cohort
time perspective: Prospective
measure: Time to dose reduction
time frame: From Day 1 up to one year
arm group label: Pentasa
description: Treatment according to standard clinical practice.
intervention type: Drug
intervention name: mesalazine
arm group label: Pentasa
other name: Pentasa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Global Clinical Compliance
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
country: Netherlands
citation: West R, Russel M, Bodelier A, Kuijvenhoven J, Bruin K, Jansen J, Van der Meulen A, Keulen E, Wolters L, Ouwendijk R, Bezemer G, Koussoulas V, Tang T, Van Dobbenburgh A, Van Nistelrooy M, Minderhoud I, Vandebosch S, Lubbinge H. Lower Risk of Recurrence with a Higher Induction Dose of Mesalazine and Longer Duration of Treatment in Ulcerative Colitis: Results from the Dutch, Non-Interventional, IMPACT Study. J Gastrointestin Liver Dis. 2022 Mar 19;31(1):18-24. doi: 10.15403/jgld-3927.
PMID: 35306553
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Mesalamine