Health Condition 1: null- Watery Diarrhea
Conditions
Interventions
Intervention1: Crofelemer, 125 mg: Oral tablet, 6 hourly for 48 hours
Intervention2: Crofelemer, 250 mg: Oral tablet, 6 hourly for 48 hours
Control Intervention1: Matching placebo: Oral tablet, 6 hour
Sponsors
Glenmark Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patient >=18 to 2. Clinical history of >=3 episodes of acute watery diarrhea. 3. Moderate to severe diarrhea based on functional impairment. 4. Able to comprehend and provide written informed consent for participating in the study, or if in case, the subject is not in the condition to provide written informed consent, consent from Legally Acceptable Representative (LAR) is acceptable. 5. Women of childbearing age or potential using adequate contraceptive measures or have been documented to be post menopausal through history taking or having been diagnosed as non pregnant by means of a Urine Pregnancy Test before randomization.
Exclusion criteria
Exclusion criteria: 1. History of receiving antimicrobial or anti diarrheal medication within 6 hours prior to administration of the Investigational Product. 2. Patients who have participated in any other interventional clinical trial within the preceding 3 months prior to enrollment in this study. 3. Patients with history of significant cardiac, hepatic, renal, cerebrovascular disease and/or other serious illnesses. 4. Any other condition which the Investigator feels will pose a significant hazard to the subject if the Investigational Product were to be administered. 5. Women who are pregnant or lactating as based on history, physical examination and clinical diagnosis or by means of a Urine Pregnancy Test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the difference in the mean stool output in grams/kg of bodyweight between placebo and any of the two active treatment groupsTimepoint: 12 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the mean frequency of diarrhea from baselineTimepoint: 12 hours & 24 hours;To compare the mean total volume of oral and or parenteral fluid rehydrationTimepoint: 48 hours;To compare the stool output in grams/kg bodyweightTimepoint: 24 hours;To evaluate the safety of the Investigational Product based on the occurrence of treatment emergent adverse events, clinically significant abnormal laboratory test values and vital signs.Timepoint: 10 days | — |
Countries
Bangladesh, India
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Limited
Outcome results
None listed