<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/NCT01687985</url>
  </required_header>
  <id_info>
    <org_study_id>BLI801-202</org_study_id>
    <nct_id>NCT01687985</nct_id>
  </id_info>
  <brief_title>A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults</brief_title>
  <official_title>A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Braintree Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Braintree Laboratories</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Success</measure>
    <time_frame>4 weeks</time_frame>
    <description>percent of patients experiencing a response in 3 out of 4 weeks of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum chemistry</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>BLI801 laxative - low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BLI801 laxative - oral solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLI801 laxative - high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BLI801 laxative - oral solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLI801 laxative - low dose</intervention_name>
    <description>BLI801 laxative - oral solution</description>
    <arm_group_label>BLI801 laxative - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLI801 laxative - high dose</intervention_name>
    <description>BLI801 laxative - oral solution</description>
    <arm_group_label>BLI801 laxative - high dose</arm_group_label>
    <other_name>BLI801</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male or female subjects at least 18 years of age&#xD;
&#xD;
        Constipated, defined by ROME definition:&#xD;
&#xD;
        Otherwise in good health, as determined by physical exam and medical history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention,&#xD;
        bowel perforation, toxic colitis, toxic megacolon&#xD;
&#xD;
        Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments&#xD;
&#xD;
        Subjects who are allergic to any BLI801 component&#xD;
&#xD;
        Subjects currently taking narcotic analgesics or other medications known to cause&#xD;
        constipation&#xD;
&#xD;
        Subjects who, in the opinion of the Investigator, should not be included in the study for&#xD;
        any reason, including inability to follow study procedures&#xD;
&#xD;
        Subjects who have participated in an investigational clinical, surgical, drug, or device&#xD;
        study within the past 30 days&#xD;
&#xD;
        Subjects with an active history of drug or alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John McGowan, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Braintree Laboratories, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commonwealth Clinical Studies</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinsearch</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memphis Gastroenterology</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <disposition_first_submitted>July 14, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>July 14, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 16, 2014</disposition_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</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>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Laxatives</mesh_term>
    <mesh_term>Cathartics</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01687985
org study id: BLI801-202
nct id: NCT01687985
lead sponsor: 
has dmc: No
A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated
      adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Treatment Success
time frame: 4 weeks
description: percent of patients experiencing a response in 3 out of 4 weeks of treatment
measure: serum chemistry
time frame: 4 weeks
arm group label: BLI801 laxative - low dose
arm group type: Experimental
description: BLI801 laxative - oral solution
arm group label: BLI801 laxative - high dose
arm group type: Experimental
description: BLI801 laxative - oral solution
intervention type: Drug
intervention name: BLI801 laxative - low dose
description: BLI801 laxative - oral solution
arm group label: BLI801 laxative - low dose
intervention type: Drug
intervention name: BLI801 laxative - high dose
description: BLI801 laxative - oral solution
arm group label: BLI801 laxative - high dose
other name: BLI801
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John McGowan, MPH
role: Study Director
affiliation: Braintree Laboratories, Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Constipation
mesh term: Laxatives
mesh term: Cathartics