None listed
Conditions
Interventions
Intervention1: Crofelemer: 250mg every 6 hours for a maximum of 3 days
Control Intervention1: Placebo: Identical tablet every 6 hours for a maximum of 3 days
Sponsors
Glenmark Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Adult male and female patients aged between 18 to 65 years 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 were recruited in the study. Female patients were either of non-childbearing potential (e.g., physiologically incapable of becoming pregnant, including surgically sterile or post-menopausal women); or childbearing potential with a negative pregnancy test at the screening/baseline assessment and using an acceptable contraceptive method approved by the investigator. Only those patients willing to give a written Informed Consent, ready to be hospitalized and willing to follow-up were included in the study.
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if the potential patient was a female who was pregnant, lactating, planning a pregnancy during the study or not practicing any form of contraception or were children or adolescent females less than 18 years age. Patients were excluded if they had known or suspected hypersensitivity to Crofelemer. Patients with chronic, iatrogenic, or bloody diarrhea with fever > 390C, those with severe dehydration, requiring hospitalization were also not included in the study. Potential patients with a history of receiving antimicrobial or antidiarrheal medication [e.g. kaolin, pectin, cholestyramine, racecadotril and opioid classes of drugs (loperamide, etc.)] within 48 hours prior to admission, those with significant cardiac, hepatic, renal, or cerebrovascular disease, or other serious illness or any condition which was likely to hamper compliance of the patient with the study protocol or unwilling to maintain their daily dairy were also excluded from the study. Patients unwilling or unable to take part in this study or those who had participated in a new drug study in past 3 months were also not included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to last unformed stool (TLUS) for consistency, stool weight, duration of diarrhea and stool frequencyTimepoint: Days 1,2 and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal Index Score (GIS)defined as the total score of all seven enteric symptoms viz. nausea, vomiting, abdominal pain or cramps, excess gas or flatulence, urgency, tenesmus and fecal incontinence and Safety measured as adverse events, serious adverse events, physical findings, clinical safety and laboratory assessmentsTimepoint: At the end of the study | — |
Countries
India
Contacts
Public ContactDr Chandrashekhar Bolmall
Outcome results
None listed