<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/NCT04458675</url>
  </required_header>
  <id_info>
    <org_study_id>250CLD</org_study_id>
    <nct_id>NCT04458675</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)</brief_title>
  <acronym>CIC</acronym>
  <official_title>A Prospective, Multicenter, Randomized, Single Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vibrant Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vibrant Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for&#xD;
      the treatment of subjects with functional Constipation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit 1 -Screening: Subjects will be screened to the study at the screening visit, PAC-QOL&#xD;
      questionnaire will be completed and subject will have a run-in time for a period of 2-3&#xD;
      weeks, assuring 14 consecutive days of eDiary with an average of &lt; 3 SBM per week.&#xD;
&#xD;
      Visit 2 - Baseline: After the run-in period, the subjects will return and eligibility will be&#xD;
      re-assessed. Subjects will be randomized to either Vibrant or Vibrant placebo for a treatment&#xD;
      period of 8 weeks. Subjects, in both arms, will have their first administration of Vibrant&#xD;
      capsule / Vibrant placebo on site at the day of baseline visit and will be instructed on&#xD;
      their treatment administration at home and will be requested to ingest the capsules at a&#xD;
      specific time of the day. At baseline, subjects will also be trained on how to use the base&#xD;
      unit at home.&#xD;
&#xD;
      Subjects will be instructed to complete a simple subject eDiary each day throughout the&#xD;
      duration of the study (including the run-in period).&#xD;
&#xD;
      The eDiary will include questions on:&#xD;
&#xD;
        -  Daily BM, SBM, CSBM&#xD;
&#xD;
        -  Change of their diet, if applicable (NOTE: the protocol will not ask/require the&#xD;
           subjects to change anything in his/her diet)&#xD;
&#xD;
        -  Change in sympotms as: brisol stool consistancy, straining, bloating, and the other&#xD;
           questions in the eDiary&#xD;
&#xD;
        -  Medication&#xD;
&#xD;
        -  AE (including diarhrea)&#xD;
&#xD;
      The first 2 weeks of treatment will be considered as a subjects' training period.&#xD;
&#xD;
      Visit 3 -after 4 weeks of treatment - an on site visit will take place to evaluate subject's&#xD;
      safety and treatment efficacy and additional capsule dispencing.&#xD;
&#xD;
      Visit 4 Final visit -after another 4 weeks of treatment - an on site visit will take place to&#xD;
      evaluate subject's safety and treatment efficacy and collect the base unites and remaning&#xD;
      capsules. PAC-QOL, Ease of use and TSQM questionnaires will be completed.&#xD;
&#xD;
      During the entire study period, data reporting will be done on an electronic Case Report Form&#xD;
      (eCRF) and an eDiary.&#xD;
&#xD;
      Subjects will be asked to refrain from taking any medication or supplement to relieve their&#xD;
      constipation, during the entire study period.&#xD;
&#xD;
      Subjects will receive phone calls at least once a week and subject compliance will be&#xD;
      monitored throughout the 8 weeks of the study.&#xD;
&#xD;
      Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel&#xD;
      movement.&#xD;
&#xD;
      Data about time of activation of the capsules will be automatically registered and&#xD;
      transmitted by the base unit for Vibrant capsules&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2018</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 7, 2019</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CSBM success rate: An increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM)</measure>
    <time_frame>change from baseline to 8 weeks</time_frame>
    <description>The primary efficacy endpoint is CSBM success rate, defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>all adverse events related and unrelated to the study treatment</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SBM success rate</measure>
    <time_frame>change from baseline to 8 weeks</time_frame>
    <description>an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 6 of the 8 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average stool consistency</measure>
    <time_frame>change from baseline to 8 weeks</time_frame>
    <description>the stool consistency is evaluated using the Bristol scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average straining</measure>
    <time_frame>change from baseline to 8 weeks</time_frame>
    <description>A sacle of 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAC-QoL</measure>
    <time_frame>change from baseline to 8 weeks</time_frame>
    <description>patient's questionnaire to evaluate quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Chronic Idiopathic Constipation</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Activr capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrant capsule</intervention_name>
    <description>The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>medical device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A biodegradable capsule, which visually similar to the Vibrant active capsule</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects aged 22 years and older&#xD;
&#xD;
          2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and&#xD;
             who have not experienced relief of their symptoms from available therapies (osmotic&#xD;
             and stimulant laxatives used for at least one month at recommended dose)&#xD;
&#xD;
          3. Subjects with an average of &lt;3 Spontaneous Bowel Movements (SBM) per week&#xD;
&#xD;
          4. Normal colonoscopy performed within 5 years prior to study participation, unless the&#xD;
             subjects are &lt;50 years old and without alarm signs and/or symptoms&#xD;
&#xD;
          5. Subject signed the Informed Consent Form (ICF)&#xD;
&#xD;
          6. Female subjects must have a negative blood pregnancy test during screening, confirmed&#xD;
             by a negative urine pregnancy test during baseline and must not be lactating prior to&#xD;
             receiving study medication. For females of child-bearing potential, a hormonal (i.e.,&#xD;
             oral, implantable, or injectable) and single-barrier method, or a double-barrier&#xD;
             method of birth control must be used throughout the study. All other female subjects&#xD;
             must have the reason for their inability to bear children documented in the medical&#xD;
             record [i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum&#xD;
             of one year since the last menstrual period)]; in these circumstances, a pregnancy&#xD;
             test will not be necessary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of complicated/obstructive diverticular disease&#xD;
&#xD;
          2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.&#xD;
&#xD;
          3. History of significant gastrointestinal disorder, including any form of inflammatory&#xD;
             bowel disease or gastrointestinal malignancy (celiac disease is accepted if the&#xD;
             subject has been treated and is in remission)&#xD;
&#xD;
          4. History of gastroparesis&#xD;
&#xD;
          5. Use of any of the following medications:&#xD;
&#xD;
               -  Medications that may affect intestinal motility, prokinetics, anti-Parkinsonian&#xD;
                  medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium&#xD;
                  hydroxide&#xD;
&#xD;
               -  With the exception of antidepressants, thyroid or hormonal replacement therapy,&#xD;
                  when the subject has been on a stable dose for at least 3 months prior to&#xD;
                  enrollment.&#xD;
&#xD;
          6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary,&#xD;
             endocrine, psychiatric or neurologic disease.&#xD;
&#xD;
          7. Presence of cardiac pacemaker or gastric electrical stimulator.&#xD;
&#xD;
          8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory&#xD;
             overeating.&#xD;
&#xD;
          9. Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically&#xD;
             significant rectocele, history of intestinal resection (with an exception for&#xD;
             appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric&#xD;
             surgery or evidence of any structural abnormality of the gastrointestinal tract that&#xD;
             might affect transit&#xD;
&#xD;
         10. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture&#xD;
             or achalasia&#xD;
&#xD;
         11. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined&#xD;
             as taking full dose NSAIDs more than three times a week for at least six months.&#xD;
             Subjects on cardiac doses of aspirin may be enrolled in the study&#xD;
&#xD;
         12. Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history&#xD;
&#xD;
         13. Participation in another clinical study within one month prior to screening.&#xD;
&#xD;
         14. Women who are pregnant or lactating&#xD;
&#xD;
         15. Use of any medication for constipation relief during the study, except as rescue&#xD;
             medication, as indicated by study rules&#xD;
&#xD;
         16. Inability to use an electronic daily Diary (on a computer, phone application, tablet&#xD;
             or other electronic device) to report bowel movements, symptoms and medication usage&#xD;
&#xD;
         17. Subject participated in a previous Vibrant study&#xD;
&#xD;
         18. Any other condition which in the opinion of the investigator may adversely affect the&#xD;
             safety of the subject or would limit the subject's ability to complete the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Health Research of Hampton Roads</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 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>Constipation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04458675
org study id: 250CLD
nct id: NCT04458675
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for
      the treatment of subjects with functional Constipation.
Visit 1 -Screening: Subjects will be screened to the study at the screening visit, PAC-QOL
      questionnaire will be completed and subject will have a run-in time for a period of 2-3
      weeks, assuring 14 consecutive days of eDiary with an average of < 3 SBM per week.

      Visit 2 - Baseline: After the run-in period, the subjects will return and eligibility will be
      re-assessed. Subjects will be randomized to either Vibrant or Vibrant placebo for a treatment
      period of 8 weeks. Subjects, in both arms, will have their first administration of Vibrant
      capsule / Vibrant placebo on site at the day of baseline visit and will be instructed on
      their treatment administration at home and will be requested to ingest the capsules at a
      specific time of the day. At baseline, subjects will also be trained on how to use the base
      unit at home.

      Subjects will be instructed to complete a simple subject eDiary each day throughout the
      duration of the study (including the run-in period).

      The eDiary will include questions on:

        -  Daily BM, SBM, CSBM

        -  Change of their diet, if applicable (NOTE: the protocol will not ask/require the
           subjects to change anything in his/her diet)

        -  Change in sympotms as: brisol stool consistancy, straining, bloating, and the other
           questions in the eDiary

        -  Medication

        -  AE (including diarhrea)

      The first 2 weeks of treatment will be considered as a subjects' training period.

      Visit 3 -after 4 weeks of treatment - an on site visit will take place to evaluate subject's
      safety and treatment efficacy and additional capsule dispencing.

      Visit 4 Final visit -after another 4 weeks of treatment - an on site visit will take place to
      evaluate subject's safety and treatment efficacy and collect the base unites and remaning
      capsules. PAC-QOL, Ease of use and TSQM questionnaires will be completed.

      During the entire study period, data reporting will be done on an electronic Case Report Form
      (eCRF) and an eDiary.

      Subjects will be asked to refrain from taking any medication or supplement to relieve their
      constipation, during the entire study period.

      Subjects will receive phone calls at least once a week and subject compliance will be
      monitored throughout the 8 weeks of the study.

      Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel
      movement.

      Data about time of activation of the capsules will be automatically registered and
      transmitted by the base unit for Vibrant capsules
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: CSBM success rate: An increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM)
time frame: change from baseline to 8 weeks
description: The primary efficacy endpoint is CSBM success rate, defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment
measure: all adverse events related and unrelated to the study treatment
time frame: through study completion, an average of 1 year
description: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measure: SBM success rate
time frame: change from baseline to 8 weeks
description: an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 6 of the 8 weeks of treatment
measure: average stool consistency
time frame: change from baseline to 8 weeks
description: the stool consistency is evaluated using the Bristol scale
measure: average straining
time frame: change from baseline to 8 weeks
description: A sacle of 0-10
measure: PAC-QoL
time frame: change from baseline to 8 weeks
description: patient's questionnaire to evaluate quality of life
arm group label: Active
arm group type: Experimental
description: Activr capsule
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule
intervention type: Device
intervention name: Vibrant capsule
description: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility
arm group label: Active
other name: medical device
intervention type: Drug
intervention name: Placebo
description: A biodegradable capsule, which visually similar to the Vibrant active capsule
arm group label: Placebo
other name: control
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Constipation
sharing ipd: No