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Crofelemer for Functional Diarrhea

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ClinicalTrials.gov Identifier: NCT04486326
Recruitment Status : Unknown
Verified August 2020 by Anthony Lembo, Beth Israel Deaconess Medical Center.
Recruitment status was:  Recruiting
First Posted : July 24, 2020
Last Update Posted : August 21, 2020
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center

Brief Summary:
The primary objectives of this study are to evaluate the clinical response of patients with diarrhea to crofelemer relative to placebo and evaluate the overall safety and tolerability of crofelemer in the treatment of diarrhea.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Crofelemer Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Crofelemer for Functional Diarrhea
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Crofelemer

Arm Intervention/treatment
Experimental: crofelemer
125mg bid
Drug: Crofelemer
Other Name: mytesi

Placebo Comparator: placebo
Drug: Placebo

Primary Outcome Measures :
  1. Bristol Stool Form Scale [ Time Frame: week 8 ]
    measures stool consistency by type from 1-7

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is a man or woman aged 18 to 65 years, inclusive, at Screening.
  2. Patient has functional diarrhea defined by the Rome IV criteria as loose (mushy) or watery stools ≥25% and hard or lumpy stools <25% of bowel movements
  3. Patient has had a colonoscopy performed:

    1. Within 10 years prior to Prescreening if patient is at least 50 years of age (alternatively, a flexible sigmoidoscopy, double contrast barium enema, or CT colonography within the past 5 years is acceptable [see recommendations of the American Cancer Society])
    2. Since the onset (if applicable) of any of the following alarm features for patients of any age (see Spiller and Thompson, 2010 - i.e. Patient has documented weight loss within the past 6 months; Patient has nocturnal symptoms; Patient has a familial history of colon cancer; or patient has blood mixed with their stool (excluding any blood from hemorrhoids).
  4. Patient has an average daily stool consistency score (BSS) of ≥5.5 on days without the use of an anti-diarrheal and at least 3 days with a BSS score ≥5 on a 1 to 7 scale over the week prior to randomization.
  5. Patient has completed the daily diary on at least 6 of the 7 days during the week prior to randomization AND at least 11 of the 14 days during the 2 weeks prior to randomization.
  6. Patient has not used loperamide rescue medication more than 4 days during the screening period.
  7. Patient is not planning to change his/her usual diet and lifestyle during the course of the study.
  8. Patient is willing to be compliant with study procedures including completing the daily diary during the screening period and throughout the study.
  9. Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study.

Exclusion Criteria:

  1. Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis, microscopic colitis) and celiac disease.
  2. Patient has a predominant symptom of abdominal pain.
  3. Patient has a history of diverticulitis within 3 months prior to screening. Patients with a history of diverticulosis are candidates for the study.
  4. Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
  5. Patient has any of the following surgical history:

    1. Any abdominal surgery within the 3 months prior to screening; or
    2. Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, cholecystectomy, hemorrhoidectomy, or polypectomy greater than 3 months are allowed). For the purposes of this study, laparoscopic surgeries without complication are considered minor and non-exclusionary, provided the condition for which the surgery was performed was not exclusionary.
  6. Patient has an unstable renal, hepatic, metabolic, or hematologic condition.
  7. Patient has a history of human immunodeficiency virus infection.
  8. Patient has a history of DSM-IV-TR-defined substance dependency, excluding nicotine and caffeine, within 2 years prior to Prescreening.
  9. Patient has a history of alcohol abuse as defined by DSM-IV-TR, binge drinking as defined by the National Institutes on Alcohol Abuse and Alcoholism, or any medical treatment for alcohol-related co-morbidities, within 5 years prior to Prescreening. Recovered alcoholics who have not consumed alcohol over the 5 years prior to Prescreening are candidates for the study.
  10. Patient has current (within 14 days of randomization) or expected use of any narcotic or opioid containing agents, tramadol
  11. Patient is unable to swallow solid, oral dosage forms whole with the aid of liquid (patients may not chew, divide, dissolve, or crush the study drug).
  12. Patient has received an investigational drug or used an investigational medical device within 30 days prior to randomization.
  13. Patient has a known pregnancy or is breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486326

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Contact: Vivian Cheng, MS, MPH 617.667.0682 vcheng2@bidmc.harvard.edu

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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Vivian Cheng, MS, MPH    617-667-0682    vcheng2@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center
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Responsible Party: Anthony Lembo, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04486326    
Other Study ID Numbers: 2020P-000464
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive