None listed
Conditions
Interventions
Intervention1: Crofelemer: 125 mg PO BID
Intervention2: Crofelemer: 250 mg PO BID
Intervention3: Crofelemer: 500 mg PO BID
Control Intervention1: Placebo: 1 tablet PO BID
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Age: 18 to 65 years. Adult male and female patients with acute diarrhea defined as the occurrence of three or more unformed stools (soft or watery consistency) within the 24 hour period preceding entry into the study. Potential female patients are of:i) Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, including surgically sterile or post-menopausal women); or ii) Childbearing potential with a negative pregnancy test at the screening/baseline visit and using an acceptable contraceptive method approved by the investigator. [Any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician.] Up to 1.5 L of IV fluid acceptable Written Informed Consent & Patient willing to follow up.
Exclusion criteria
Exclusion criteria: The potential patient is a woman who is pregnant, lactating, planning a pregnancy during the study or not practicing any form of contraception Children or adolescent females less than 18 years age. Patients who develop hypersensitivity to crofelemer /placebo after dosing. Patients with chronic, iatrogenic, or bloody diarrhea with fever > 390C. Patients with severe dehydration, requiring IV fluids &/or antibiotics. Patients with HIV associated diarrhea The potential patient has a history of receiving antimicrobial or antidiarrheal medication [e.g. kaolin, pectin, cholestyramine, racecadotril and opioid classes of drugs (loperamide, lomotil, etc.)] within 48 hours prior to admission. Patients with significant cardiac, hepatic, renal, diabetic or cerebrovascular disease, or other serious illness. Any condition which is likely to hamper compliance of the patient with the study protocol or unwilling to maintain their daily dairy. The potential patient is unwilling or unable to take part in this study. Participated in a new drug study in past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of diarrhea: Hours from first dose of study drug until last unformed stool before diarrhea resolution.Timepoint: Days 1, 2 & 3;Resolution of Diarrhea: No stool for 12 hours or passage of two consecutive formed stoolsTimepoint: Days 1, 2 & 3;Stool frequency: Reduction in number of stools per day at the end of 3 days of therapy.Timepoint: Days 1, 2 & 3;Stool Weight: Change of stool weight in grams.Timepoint: Days 1, 2 & 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response: Percentage of patients with Clinical success / treatment failure.Timepoint: Day 3;Improvement in enteric symptoms i.e. GIS from baseline.Timepoint: Days 1, 2 & 3;Safety and tolerabilityTimepoint: Day 3 | — |
Countries
India
Contacts
Public ContactDr Chandrashekhar Bolmall
Outcome results
None listed