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Anti-Diarrheal Agent
Crofelemer for Functional 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
- Diarrhea
- Bile Acid Diarrhea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
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 • NCT0137449017%
Upper respiratory tract infection
12%
Parasitic infection intestinal
8%
Giardiasis
6%
Bronchitis
6%
Constipation
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
859 Previous Clinical Trials
12,932,479 Total Patients Enrolled
1 Trials studying Diarrhea
180 Patients Enrolled for Diarrhea
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
1 Trials studying Diarrhea
180 Patients Enrolled for Diarrhea