Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mepo for EoE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656380
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : January 28, 2021
Sponsor:
Collaborators:
GlaxoSmithKline
University of Utah
Northwestern University
MNGI Digestive Health, P.A.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE September 4, 2018
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE March 20, 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Mean Change in Dysphagia from Baseline to 3 months Post-treatment [ Time Frame: Baseline, Month 3 Post-Treatment ]
Dysphagia will be assessed by the Eosinophilic Esophagitis Symptom Activity Index (EEsAI) which measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Proportion of Participants with a Clinical Remission (EEsAI Score of ≤ 20 points) after 3 months of treatment [ Time Frame: After 3 months of treatment ]
    The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
  • Proportion of Participants with a Clinical Response (EEsAI Score Decrease of ≥ 20 points) after 3 months of treatment [ Time Frame: After 3 months of treatment ]
    The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
  • Absolute Peak Eosinophil count (measured in eos/hpf) after 3 months of treatment [ Time Frame: After 3 months of treatment ]
    Absolute peak eosinophil count (measured in EOS/hpf) after 3 months of treatment.
  • Histologic Response Levels after 3 Treatment Months [ Time Frame: After 3 months of treatment ]
    Histologic levels for <15, ≤ 6, and ≤ 1 EOS/hpf.
  • Mean Change in EoE Endoscopic Reference Score (EREFS) from Baseline to 3 months Post-treatment [ Time Frame: Baseline, 3 months post-treatment ]
    Mean change in severity of endoscopic findings as measured by the EoE Endoscopic Reference Score (EREFS). The EREFS, measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema and furrows as absent (0) or present (1); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9).
  • Mean change in the Straumann Dysphagia Instrument (SDI) Score from Baseline to 3 months Post-treatment [ Time Frame: Baseline, 3 months post-treatment ]
    The Straumann Dysphagia Instrument (SDI) is a direct measure of dysphagia frequency and severity which is completed by participants and reported over the previous week. The score ranges from 0-9, with higher scores indicating more severe dysphagia.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Proportion of Participants with a Clinical Remission (EEsAI Score of ≤ 20 points) after 3 months of treatment [ Time Frame: After 3 months of treatment ]
    The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
  • Proportion of Participants with a Clinical Remission (EEsAI Score of ≤ 20 points) between participants initially randomized to active medication following 6 treatment months and participants initially randomized to placebo following 3 treatment months. [ Time Frame: Baseline-6 months for active arm; baseline-3 months for placebo arm ]
    The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission. This will be compared between the groups using analysis of covariance.
  • Proportion of participants initially randomized to placebo with clinical remission (EEsAI score of ≤ 20) at Month 6 [ Time Frame: Month 6 ]
    Comparisons will be made using a two sample t-test
  • Proportion of Participants with a Clinical Remission(EEsAI Score of ≤20 points)between those initially randomized to active medication following 3 treatment months and those initially randomized to placebo following 3 active treatment months (Month 6) [ Time Frame: Baseline- 3 months for active arm; 3 months-6 months for those initially randomized to placebo ]
    The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission. This will be compared between the groups using analysis of covariance.
  • Proportion of Participants with a Clinical Response (EEsAI Score Decrease of ≥ 20 points) after 3 months of treatment [ Time Frame: After 3 months of treatment ]
    The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
  • Proportion of Participants with Clinical Response(EEsAI Score Decrease of ≥20 points)between participants initially randomized to active medication following 6 treatment months and participants initially randomized to placebo following 3 treatment months [ Time Frame: Baseline-6 months for active arm; baseline-3 months for placebo arm ]
    The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission. This will be compared between the groups using analysis of covariance.
  • Proportion of Participants initially randomized to placebo with a clinical response (EEsAI score decrease of ≥20 points) at Month 6 [ Time Frame: 6 months ]
    Comparisons will be made using a two-sample t-test
  • Proportion of Participants with Clinical Response(EEsAI Score Decrease of ≥20 points)between those initially randomized to active medication following 3 treated months and those initially randomized to placebo following 3 active months (month 6) [ Time Frame: Baseline- 3 months for active arm; 3 months-6 months for those initially randomized to placebo ]
    The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
  • Absolute Peak Eosinophil count (measured in eos/hpf) after 3 months of treatment [ Time Frame: After 3 months of treatment ]
    Absolute peak eosinophil count (measured in EOS/hpf) after 3 months of treatment.
  • Absolute Peak Eosinophil count (measured in eos/hpf) between participants initially randomized to active medication following 6 treatment months and participants initially randomized to placebo following 3 treatment months. [ Time Frame: Baseline-6 months for active arm; baseline-3 months for placebo arm ]
    Absolute peak eosinophil count (measured in EOS/hpf) after 3 months of treatment using two-sample t-test.
  • Absolute Peak Eosinophil count (measured in eos/hpf) of participants initially randomized to placebo following 3 active treatment months [ Time Frame: Month 3-Month 6 ]
    Absolute peak eosinophil count (measured in EOS/hpf) after 3 months of treatment. Comparisons will be made using a two-sample t-test
  • Absolute Peak Eosinophil count (measured in eos/hpf) between those initially randomized to active medication following 3 treatment months and participants initially randomized to placebo following 3 active treatment months (month 6) [ Time Frame: Baseline- 3 months for active arm; 3 months-6 months for those initially randomized to placebo ]
    Absolute peak eosinophil count (measured in EOS/hpf) using two-sample t-tests
  • Histologic Response Levels after 3 Treatment Months [ Time Frame: After 3 months of treatment ]
    Histologic levels for <15, ≤ 6, and ≤ 1 EOS/hpf.
  • Histologic Response Levels between participants initially randomized to active medication following 6 treatment months and participants initially randomized to placebo following 3 treatment months [ Time Frame: Baseline-6 months for active arm; baseline-3 months for placebo arm ]
    Histologic levels for <15, ≤ 6, and ≤ 1 EOS/hpf using chi-square analysis
  • Histologic Response Levels with participants initially randomized to placebo following 3 months of active treatment [ Time Frame: Month 3-Month 6 ]
    Histologic levels for <15, ≤ 6, and ≤ 1 EOS/hpf. Comparisons will be made using McNemar's test
  • Histologic Response Levels between those initially randomized to active medication following 3 treatment months and participants initially randomized to placebo following 3 active treatment months (month 6) [ Time Frame: Baseline- 3 months for active arm; 3 months-6 months for those initially randomized to placebo ]
    Histologic levels for <15, ≤ 6, and ≤ 1 EOS/hpf using chi square analysis
  • Mean Change in EoE Endoscopic Reference Score (EREFS) from Baseline to 3 months Post-treatment [ Time Frame: Baseline, 3 months post-treatment ]
    Mean change in severity of endoscopic findings as measured by the EoE Endoscopic Reference Score (EREFS). The EREFS, measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema and furrows as absent (0) or present (1); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9).
  • Mean Change in EoE Endoscopic Reference Score (EREFS) between participants initially randomized to active medication following 6 treatment months and participants initially randomized to placebo following 3 treatment months [ Time Frame: Baseline-6 months for active arm; baseline-3 months for placebo arm ]
    Mean change in severity of endoscopic findings as measured by the EoE Endoscopic Reference Score (EREFS). The EREFS, measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema and furrows as absent (0) or present (1); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9).
  • Mean Change in severity of endoscopic findings as measured by the EoE Endoscopic Reference Score (EREFS) in participants initially randomized to placebo after 3 months of active treatment [ Time Frame: Month 3-Month 6 ]
    Mean change in severity of endoscopic findings as measured by the EoE Endoscopic Reference Score (EREFS). The EREFS, measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema and furrows as absent (0) or present (1); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9). Comparisons will be made using a two sample t-test
  • Mean Change in EoE Endoscopic Reference Score (EREFS) between those initially randomized to active medication following 3 treatment months and participants initially randomized to placebo following 3 active treatment months (month 6) [ Time Frame: Baseline- 3 months for active arm; 3 months-6 months for those initially randomized to placebo ]
    Mean change in severity of endoscopic findings as measured by the EoE Endoscopic Reference Score (EREFS). The EREFS, measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema and furrows as absent (0) or present (1); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9).
  • Mean change in the Straumann Dysphagia Instrument (SDI) Score from Baseline to 3 months Post-treatment [ Time Frame: Baseline, 3 months post-treatment ]
    The Straumann Dysphagia Instrument (SDI) is a direct measure of dysphagia frequency and severity which is completed by participants and reported over the previous week. The score ranges from 0-9, with higher scores indicating more severe dysphagia.
  • Mean change in the Straumann Dysphagia Instrument (SDI) Score between participants initially randomized to active medication following 6 treatment months and participants initially randomized to placebo following 3 treatment months [ Time Frame: Baseline-6 months for active arm; baseline-3 months for placebo arm ]
    The Straumann Dysphagia Instrument (SDI) is a direct measure of dysphagia frequency and severity which is completed by participants and reported over the previous week. The score ranges from 0-9, with higher scores indicating more severe dysphagia.
  • Mean change in the Straumann Dysphagia Instrument (SDI) Score will be compared in participants initially randomized to placebo after 3 months of active treatment [ Time Frame: Month 3-Month 6 ]
    The Straumann Dysphagia Instrument (SDI) is a direct measure of dysphagia frequency and severity which is completed by participants and reported over the previous week. The score ranges from 0-9, with higher scores indicating more severe dysphagia. Comparisons will be made using a two sample t-test
  • Mean change in the Straumann Dysphagia Instrument (SDI) Score between those initially randomized to active medication following 3 treatment months and participants initially randomized to placebo following 3 active treatment months (month 6) [ Time Frame: Baseline- 3 months for active arm; 3 months-6 months for those initially randomized to placebo ]
    The Straumann Dysphagia Instrument (SDI) is a direct measure of dysphagia frequency and severity which is completed by participants and reported over the previous week. The score ranges from 0-9, with higher scores indicating more severe dysphagia.
  • Mean change in Peripheral Blood Eosinophil Levels from baseline to 3 months post-treatment. [ Time Frame: Baseline, 3 months post-treatment ]
    This change will be analyzed in comparison between the groups after 3 months of treatment.
  • Mean change in Peripheral Blood Eosinophil Levels between participants initially randomized to active medication following 6 treatment months and participants initially randomized to placebo following 3 treatment months [ Time Frame: Baseline-6 months for active arm; baseline-3 months for placebo arm ]
    This change will be analyzed in comparison between the groups after 3 months of treatment.
  • Mean change in Peripheral Blood Eosinophil Levels will be compared in participants initially randomized to placebo after 3 months of active treatment [ Time Frame: Month 3-Month 6 ]
    Comparisons will be made using a two sample t-test
  • Mean change in Peripheral Blood Eosinophil Levels between those initially randomized to active medication following 3 treatment months and participants initially randomized to placebo following 3 active treatment months (Month 6) [ Time Frame: Baseline- 3 months for active arm; 3 months-6 months for those initially randomized to placebo ]
    This change will be analyzed in comparison between the groups after 3 months of treatment.
  • Adverse events and safety will be assessed during all time points in the study. Adverse events of interest, including food impaction, anaphylactic reactions, injection site reactions, and infections will be compared between groups by chi-square [ Time Frame: baseline, month 3 post treatment, month 6 post treatment ]
    These events which have been defined in the protocol will be compared between treatment groups by chi-square
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mepo for EoE Study
Official Title  ICMJE A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms
Brief Summary Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis after an initial 3 month treatment course, and will also assess the impact of an additional 3 months of treatment.
Detailed Description

This is a multi-center, randomized, double blind, parallel-arm, placebo controlled trial of mepolizumab. After the first 3 month blinded phase, there will be a second 3 month blinded phase where all patients receive active medication, but the dose will be lower in the subjects initially randomized to the placebo arm.

In the first arm, subjects will receive mepolizumab 300 mg SQ monthly for 3 months. In the second arm, subjects will receive a placebo SQ injection monthly for 3 months. Both groups will have the injection administered under direct observation in a Clinical & Translational Research Center (CTRC) or other clinic to ensure proper administration and compliance. Each visit will also provide an opportunity for symptom questionnaires to be completed and for blood samples to be drawn. After 3 months (the time point where the primary outcome is assessed), all subjects initially randomized to active treatment will continue with mepolizumab dosing 300 mg SQ monthly, and will remain blinded. All subjects initially randomized to placebo will receive mepolizumab 100mg SQ monthly, and will remain blinded. Of note, no dietary changes, changes in baseline Proton Pump Inhibitor (PPI) medication dose, changes in inhaled or intranasal steroid doses, or administration or oral, topical/swallowed, or systemic steroids will be allowed during the study period. Subjects will undergo endoscopy after the first blinded phase (at 3 months) and after the second blinded phase (after 6 months).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • EoE
  • Eosinophilic Esophagitis
Intervention  ICMJE
  • Drug: Mepolizumab 300 mg
    Mepolizumab 300 mg subcutaneous injection
    Other Name: Nucala
  • Drug: Mepolizumab 100 mg
    Mepolizumab 100 mg subcutaneous injection
    Other Name: Nucala
  • Other: Placebo
    Saline subcutaneous injection
    Other Name: Saline
Study Arms  ICMJE
  • Experimental: Mepolizumab 300 mg
    Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
    Intervention: Drug: Mepolizumab 300 mg
  • Placebo, followed by Mepolizumab 100 mg
    This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
    Interventions:
    • Drug: Mepolizumab 100 mg
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 16-75
  • Diagnosis of EoE as per consensus guidelines (including PPI non-response). PPI non-response is defined as >15 EOS/hpf after 8 weeks of high dose administration (40mg total per day or higher) of any approved PPI medication.
  • Active eosinophilia on esophageal biopsy, with a peak count of least 15 EOS/hpf from at least one esophageal level.
  • Biopsies from the stomach and duodenum that have ruled out alternative etiologies in all children and in adults with abnormal endoscopic findings or when other gastric or small intestinal conditions are clinical possibilities. If these samples have been obtained during a previous endoscopic evaluation and in the judgement of the site-Investigator the patient has not had a clinically significant change that would merit repeat gastric/duodenal biopsies, then prior normal gastric and duodenal biopsies are acceptable to exclude alternate etiologies.
  • Active symptoms of dysphagia with more than 3 episodes of dysphagia over a period of 2 weeks during the screening period, and an Eosinophilic Esophagitis Symptom Activity Index (EEsAI; see below for details) score of ≥ 27 at baseline.
  • Able to read, comprehend, and sign consent form.
  • Have maintained a stable diet for 6 weeks prior to enrollment.
  • Able to maintain a stable diet throughout the duration of the study period.
  • Female subjects of childbearing potential who have had their first menses agree to use a highly effective method of birth control during the study and for 30 days after the last dose of study drug. Female subjects with reproductive potential who are using systemic contraceptives (e.g., oral contraceptives, injectable contraceptives, implantable/insertable hormonal contraceptive products, or transdermal patches) to prevent pregnancy must have stable use for ≥28 days prior to screening. See section 5.3 for additional details.

Exclusion Criteria:

  • Esophageal dilation within 8 weeks of the screening endoscopy.
  • Inability to pass a standard upper endoscope (8-10mm) due to esophageal narrowing or stricturing.
  • Swallowed/topical steroids for EoE within 4 weeks of the screening endoscopy, or systemic corticosteroids within 8 weeks of the screening endoscopy.
  • Not having maintained a stable diet for at least 6 weeks preceding enrollment.
  • Initiation, discontinuation, or change of dose regimen of PPIs; leukotriene inhibitors; or nasal, inhaled, and/or orally administered topical corticosteroids for any condition (such as gastroesophageal reflux disease, asthma, or allergic rhinitis) within the 8 weeks prior to the qualifying esophagogastroduodenoscopy (EGD).
  • Presence of concomitant eosinophilic gastritis (EG), eosinophilic gastroenteritis (EGE), eosinophilic colitis (EC), Crohn's disease, ulcerative colitis, or celiac disease.
  • History of malignancy within 5 years prior to screening, except completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
  • History of achalasia.
  • Prior esophageal surgery.
  • History of bleeding disorder or esophageal varices.
  • Active parasitic infection or suspicion of an active parasitic infection, which, in the opinion of the site-Investigator, has not been previously evaluated or treated. Subjects presenting with signs of active parasitic infection or suspicion of active parasitic infection as assessed by current diarrhea and/or blood or mucus in stool will be referred to their clinical physician for further testing to rule out parasitic infection.
  • Any other active infections judged at the discretion of the site-Investigator.
  • Any other medical or psychological condition that, in the opinion of the site-investigator, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments. The specific justification for patients excluded under this criterion will be noted in study documents.
  • Patient or his/her immediate family is a member of the investigational team.
  • Pregnancy or breastfeeding.
  • Women of children bearing potential who are not on highly-effective contraception.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Susan E Moist, MPH 919-966-7655 susan_moist@med.unc.edu
Contact: Lindsay M Cortright, MA 919-445-0203 lindsay_cortright@med.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03656380
Other Study ID Numbers  ICMJE 18-0431
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • GlaxoSmithKline
  • University of Utah
  • Northwestern University
  • MNGI Digestive Health, P.A.
Investigators  ICMJE
Principal Investigator: Evan S Dellon, MD, MPH UNC Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP