| CTRI Number |
CTRI/2011/11/002156 [Registered on: 22/11/2011] Trial Registered Prospectively |
| Last Modified On: |
26/06/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Crofelemer tablets in the treatment of watery diarrhea in hospitalized adult patients. |
|
Scientific Title of Study
|
A double blind, randomized, placebo controlled, parallel group, three arm, multicenter and multinational pivotal study to assess the efficacy and safety of two dosage regimens of Crofelemer tablets in the treatment of moderate to severe acute watery diarrhea in adult patients. |
| Trial Acronym |
C FORWARD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C003 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Lalit Lakhwani |
| Designation |
Sr. Manager - Clinical Sciences |
| Affiliation |
Glenmark Pharmaceuticals Limited |
| Address |
Glenmark Pharmaceuticals Limited
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
Thane
MAHARASHTRA
400709
India |
| Phone |
022-67720000 |
| Fax |
|
| Email |
lalitl@glenmarkpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Sachan |
| Designation |
Manager-Clinical Research |
| Affiliation |
Glenmark Pharmaceuticals Limited |
| Address |
Glenmark Pharmaceuticals Limited
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
Thane
MAHARASHTRA
400709
India |
| Phone |
022-67720000 |
| Fax |
|
| Email |
shailendrasachan@glenmarkpharma.com |
|
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Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Limited |
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Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Limited |
| Address |
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai, India- 400709 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
Bangladesh
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhabadev Goswami |
Institute of Digestive and Liver Diseases |
Dispur Hospitals Ltd. Campus, Ganeshguri, Guwahati
Kamrup
ASSAM |
0361-2221962
bhabadev@rediffmail.com |
| Dr Sanjib Mohanty |
ISPAT General Hospital, Rourkela |
Deapartment of Internal Medicine and Critical Care, ISPAT General Hospital
Sector 19, Rourkela
Sundargarh
ORISSA |
0661-2642137
sanjibmalaria@rediffmail.com |
| Dr Vijay G Somanavar |
K.L.E.S. Prabhakar Kore’s Hospital & Medical Research Centre |
Department of General Medicine, KLES Prabhakar Kore’s Hospital & Medical Research Centre, Nehru Nagar, Belgaum
Belgaum
KARNATAKA |
0831-2470400
sharveel@yahoomail.co.in |
| Dr N D Moulick |
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General |
Department of Medicine, Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Sion
Mumbai
MAHARASHTRA |
022-24076381
ndmoulick@rediffmail.com |
| Dr Sandeep Kumar Gupta |
M.V. Hospital and Research Center |
314/30, Mirza Mandi, Chowk
Lucknow
UTTAR PRADESH |
0522-2258215
mvhrclko@rediffmail.com |
| Dr D P Agarwal |
Madhuraj Hospital Pvt. Ltd |
113/l2l A, Swaroop Nagar
Kanpur Nagar
UTTAR PRADESH |
09415051160
drdpagarwal58@gmail.com |
| DrMrs HR Salkar |
N. K. P. Salve & Lata Mangeshkar Hospital |
Department of Medicine, N. K. P. Salve & Lata Mangeshkar Hospital, Digdoh, Hingna Road
Nagpur
MAHARASHTRA |
07104-236290
rgsalkar@rediffmail.com |
| Dr Sanjay Gupta |
Pushkar Raj Hospital |
Hotel Goyal Inn Complex, Near Gurudwara
Ajmer
RAJASTHAN |
0145-2772928
s.guptaji1967@gmail.com |
| Dr Yogesh Sharma |
Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital |
Department of Medicine, Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Kalwa
Thane
MAHARASHTRA |
022-25347727
dryogeshsharmaMD@yahoo.com |
| Dr Hemant Gupta |
Samvedna Hospital |
B27/88G Ravindrapuri
Varanasi
UTTAR PRADESH |
0542-2420546
hemantg26@yahoo.com |
| Dr Manjunath Muniraju |
Sapthagiri Institute of Medical Science and Research Center |
# 15, Chikkasandra, Hesarghatta Main Road, Bangalore - 560090
Bangalore
KARNATAKA |
09986143260
manju2586_suri@rediffmail.com |
| Dr Shyam Sunder Sharma |
Sawai Mansingh (SMS) Medical College |
Sawai Mansingh (SMS) Medical College,JLN Marg, Adarsh Nagar
Jaipur
RAJASTHAN |
0141-2560291
shyamsharma4@rediffmail.com |
| Dr Dilip Mahalanabis |
Society for Applied Studies, NICED, ID & BG Hospital |
Society for Applied Studies
CF-198, Ground Floor, Salt Lake, Sector 1
Kolkata
WEST BENGAL |
033-23588850
dilipm198@yahoo.com |
| Dr Girish Rajadhyaksha |
T. N. Medical College & B. Y. L. Nair Ch. Hospital |
Department of Medicine, T. N. Medical College & B. Y. L. Nair Ch. Hospital, Dr. A L Nair road, Mumbai Central
Mumbai
MAHARASHTRA |
022-23027122
girishraj63@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethics Committee of B.Y.L.Nair Charitable Hospital & T.N. Medical College, Mumbai |
Submittted/Under Review |
| Ethics Committee, KLE University, Belgaum |
Approved |
| Ethics Review Committee, SAS, Kolkata |
Approved |
| Independent Ethics Committee, Jaipur |
Approved |
| Institutional Clinical Ethics Committee, RGMC, Thane |
Approved |
| Institutional Ethics Committee(IEC) |
Approved |
| Institutional Ethics Committee, NKPSIMS & LMH, Nagpur |
Approved |
| Institutional Review Board (Ethical Committee), Rourkela |
Approved |
| Madhuraj Nursing Home Ethics Comittee, Kanpur |
Approved |
| Office of the Ethics Committee (EC), SMS Medical college & Attached Hospital, Jaipur |
Approved |
| Samvedna Hospital, Ethics Committee, Varanasi |
Approved |
| Sapthagiri Institute of Medical Science and Research Center Institutional Ethics Committee (IEC) |
Approved |
| Staff & Research Society, L.T.M.M.C. & L.T.M.G.H., Mumbai |
Approved |
| The Ethics Committee, Dispur Hospitals Pvt Ltd., Guwahati |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Watery Diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Crofelemer, 125 mg |
Oral tablet, 6 hourly for 48 hours |
| Intervention |
Crofelemer, 250 mg |
Oral tablet, 6 hourly for 48 hours |
| Comparator Agent |
Matching placebo |
Oral tablet, 6 hourly for 48 hours |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
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Target Sample Size
|
Total Sample Size="717"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/11/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
22/11/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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.
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. |