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Anti-Diarrheal Agent

Crofelemer for Traveler's Diarrhea

Phase 4
Waitlist Available
Led By Anthony Lembo, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing crofelemer, a medication aimed at reducing diarrhea. It targets patients who are experiencing diarrhea to see if the drug can help them and to ensure it is safe. Crofelemer works by blocking channels in the intestines to reduce water secretion, which can help lessen diarrhea. Crofelemer is a newly approved medication for the symptomatic relief of non-infectious diarrhea in adult patients with HIV on anti-retroviral therapy.

Eligible Conditions
  • Traveler's Diarrhea
  • Diarrhea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bristol Stool Form Scale

Side effects data

From 2012 Phase 3 trial • 250 Patients • NCT01374490
17%
Upper respiratory tract infection
12%
Parasitic infection intestinal
8%
Giardiasis
6%
Constipation
6%
Bronchitis
6%
Nausea
5%
Blastocystis infection
2%
CELLULITIS
1%
SUICIDE ATTEMPT
1%
PAIN IN EXTREMITY
100%
80%
60%
40%
20%
0%
Study treatment Arm
Crofelemer

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: crofelemerExperimental Treatment1 Intervention
125mg bid
Group II: placeboPlacebo Group1 Intervention
bid
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crofelemer
FDA approved

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,944 Total Patients Enrolled
Anthony Lembo, MDPrincipal Investigator - Beth Israel Deaconess Medical Center
Associated Physicians of Hmfp@Bidmc, Beth Israel Deaconess Medical Center
Tufts University School Of Medicine (Medical School)
La Co Olive View M C (Residency)
5 Previous Clinical Trials
1,314 Total Patients Enrolled
~3 spots leftby Nov 2025
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