A clinical trial to study the effects of Crofelemer tablets in the treatment of watery diarrhea in hospitalized adult patients.
- Conditions
- Health Condition 1: null- Watery Diarrhea
- Registration Number
- CTRI/2011/11/002156
- Lead Sponsor
- Glenmark Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 717
1. Male or female patient >=18 to <=65 years.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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