A clinical trial to study the effects of Crofelemer tablets in the treatment of watery diarrhea in hospitalized adult patients.

Phase 3

Completed

• Conditions: Watery Diarrhea

• Registration Number: CTRI/2011/11/002156
• Lead Sponsor: Glenmark Pharmaceuticals Limited

Brief Summary

This is a randomized, double-blind, placebo controlled, parallel group, three arms, pivotal study. The study will be conducted in hospitalized adult patients with a moderate to severe acute watery diarrhea. A total of 717 patients will be enrolled across the multicenter from India and Bangladesh. Patients will be recruited after obtaining written informed consent. After screening and rehydration for four hours, patients with adequate hydration, will be randomized in 1:1:1 ratio to receive either one of the two dose regimens of Crofelemer or placebo. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

The primary objective of the study is to compare the difference in the mean stool output in grams/kg of bodyweight between Placebo and any of the two active treatment groups after the first dose of the Investigational Product at 0 hours to the end of the first 12 hours post dose. Secondary objectives of the study are: to compare the stool output in grams/kg bodyweight at 24 hours post dose and till recovery, to compare the mean frequency of diarrhea post dose, to compare the mean total volume of oral and or parenteral fluid rehydration from the start of treatment till the end of 48 hours and to evaluate the safety of the Investigational Product.

Patient will be followed for safety and efficacy at every 6 hours after IP administration till 48 hours then after at every 24 hours till discharge. There will be a follow-up visit at day 10 after the discharge.

As per DCGI direction, electolyte balance and incidence of occurance of hypertension will be monitored in placebo group during the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-22
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 717

Inclusion Criteria

• Male or female patient ≥18 to ≤65 years.
• Clinical history of ≥3 episodes of acute watery diarrhea.
• Moderate to severe diarrhea based on functional impairment.
• 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.
• 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

• History of receiving antimicrobial or anti diarrheal medication within 6 hours prior to administration of the Investigational Product.
• Patients who have participated in any other interventional clinical trial within the preceding 3 months prior to enrollment in this study.
• Patients with history of significant cardiac, hepatic, renal, cerebrovascular disease and/or other serious illnesses.
• Any other condition which the Investigator feels will pose a significant hazard to the subject if the Investigational Product were to be administered.

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 groups	12 hours

Secondary Outcome Measures

Name	Time	Method
To compare the stool output in grams/kg bodyweight	24 hours
To compare the mean frequency of diarrhea from baseline	12 hours & 24 hours
To compare the mean total volume of oral and or parenteral fluid rehydration	48 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.	10 days

Trial Locations

Locations (14)

Institute of Digestive and Liver Diseases; 🇮🇳 Kamrup, ASSAM, India

ISPAT General Hospital, Rourkela; 🇮🇳 Sundargarh, ORISSA, India

K.L.E.S. Prabhakar Kore’s Hospital & Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General; 🇮🇳 Mumbai, MAHARASHTRA, India

M.V. Hospital and Research Center; 🇮🇳 Lucknow, UTTAR PRADESH, India

Madhuraj Hospital Pvt. Ltd; 🇮🇳 Nagar, UTTAR PRADESH, India

N. K. P. Salve & Lata Mangeshkar Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Pushkar Raj Hospital; 🇮🇳 Ajmer, RAJASTHAN, India

Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Samvedna Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

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Institute of Digestive and Liver Diseases

🇮🇳Kamrup, ASSAM, India

Dr Bhabadev Goswami

Principal investigator

bhabadev@rediffmail.com