| CTRI Number |
CTRI/2009/091/000934 [Registered on: 04/01/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
A clinical trial to study the effect, Safety and Tolerability of Crofelemer in the Treatment of Adult Acute Infectious Diarrhea |
|
Scientific Title of Study
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A Double-Blind, Randomized, Four Arm, Dose Ranging (Phase IIb) Study to Assess the Efficacy, Safety and Tolerability of Crofelemer in the Treatment of Adult Acute Infectious Diarrhea |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GL/CRO/08-09 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandrashekhar Bolmall |
| Designation |
|
| Affiliation |
|
| Address |
Medical Services Department
Glenmark Pharmaceuticals Ltd
Mumbai
MAHARASHTRA
400099
India |
| Phone |
91-22-40189999 |
| Fax |
91-22-40189990 |
| Email |
chandrashekharb@glenmarkpharma.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar Bolmall |
| Designation |
|
| Affiliation |
|
| Address |
Medical Services Department
Glenmark Pharmaceuticals Ltd
Mumbai
MAHARASHTRA
400099
India |
| Phone |
91-22-40189999 |
| Fax |
91-22-40189990 |
| Email |
chandrashekharb@glenmarkpharma.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekhar Bolmall |
| Designation |
|
| Affiliation |
|
| Address |
Medical Services Department
Glenmark Pharmaceuticals Ltd
Mumbai
MAHARASHTRA
400099
India |
| Phone |
91-22-40189999 |
| Fax |
91-22-40189990 |
| Email |
chandrashekharb@glenmarkpharma.com |
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Source of Monetary or Material Support
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| Glenmark Pharmaceuticals Ltd |
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Primary Sponsor
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| Name |
Glenmark Pharmaceuticals Ltd |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Dinakaran |
CSI Kalyani General Hospital |
15,Dr. Radhakrishnan Salai,-600004
Chennai
TAMIL NADU |
9841151599
poornimayadav@gmail.com |
| Dr. Tapas Das |
Institute of PostGraduate Medical Education and Research |
244, A.J.C Bose Road,-700020
Kolkata
WEST BENGAL |
9830583864
doctor_tdas@yahoo.co.in |
| Dr. Alaka Deshpande |
J. J. Hospital |
J J Marg,Byculla-400008
Mumbai
MAHARASHTRA |
98691 68886
alakadeshpande@rediffmail.com |
| Dr. N.D.Moulick |
Lokmanya Tilak Muncipal Medical College & Lokmanya Tilak Muncipal General Hospital |
Prof. & Head, Dept. of Medicine,Sion-400022
Mumbai
MAHARASHTRA |
9323609966
ndmoulick@rediffmail.com |
| Dr. B. Prabhakar |
Osmania General Hospital |
Department of gastroenetrology an dlIver Care Unit,-500012
Hyderabad
ANDHRA PRADESH |
9848029112
bprabhakardr@yahoo.com |
| Dr. Rakesh Kochhar |
Postgraduate Institute of Medical Education and Research |
Unit II Head,Department of Gastroenterology-160012
Chandigarh
CHANDIGARH |
9815699565
dr_kochhar@hotmail.com |
| Dr S D Tarey |
St John's Medical College and Hospital |
Department of Medicine,-560034
Bangalore
KARNATAKA |
9611254738
tareys@gmail.com |
| Dr. Girish Rajadhyaksha |
T.N Medical College and B.Y.L Nair Hospital |
Medicine Department,Mumbai Central-400008
Mumbai
MAHARASHTRA |
9821695349
girishraj63@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| BYL Nair and T N Medical College |
Approved |
| CSI Kalyani General Hospital |
Approved |
| Grant Medical College and J j Group of Hospitals |
Approved |
| Institute of Postgraduate Medical Education and Research, Kolkata |
Approved |
| Lokmanya Tilak Municipal Medical College and Lokmanya Tilak Municipal General Hospital |
Approved |
| Osmania Medical College |
Approved |
| Postgarduate Institute of Medical Education and Research, Chandigarh |
Approved |
| St John's Medical College Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Infectious Diarrhea, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Crofelemer |
125 mg PO BID |
| Intervention |
Crofelemer |
250 mg PO BID |
| Intervention |
Crofelemer |
500 mg PO BID |
| Comparator Agent |
Placebo |
1 tablet PO BID |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
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.
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| ExclusionCriteria |
| Details |
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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Duration of diarrhea: Hours from first dose of study drug until last unformed stool before diarrhea resolution. |
Days 1, 2 & 3 |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Improvement in enteric symptoms i.e. GIS from baseline. |
Days 1, 2 & 3 |
| Clinical response: Percentage of patients with Clinical success / treatment failure. |
Day 3 |
| Safety and tolerability |
Day 3 |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/09/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The study is a randomized, double-blind, parallel group, multicentre trial comparing the safety and efficacy of different doses of Crofelemer in patients with acute infectious diarrhea. |