| CTRI Number |
CTRI/2010/091/001096 [Registered on: 12/08/2010] |
| Last Modified On: |
28/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Ulinastatin as an adjuvant therapy in treatment of mild or severe acute pancreatitis |
|
Scientific Title of Study
|
A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Ulinastatin versus placebo alongwith standard supportive care in subjects with mild or severe acute pancreatitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSV-UTI-AP-0110 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. P. Abraham |
| Designation |
|
| Affiliation |
|
| Address |
P D Hinduja Hospital
Mahim
Mumbai
MAHARASHTRA
400016
India |
| Phone |
022-24447104 |
| Fax |
|
| Email |
dr_pabraham@hindujahospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. P. Abraham |
| Designation |
|
| Affiliation |
|
| Address |
P D Hinduja Hospital
Mahim
Mumbai
MAHARASHTRA
400016
India |
| Phone |
022-24447104 |
| Fax |
|
| Email |
dr_pabraham@hindujahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs. Naju Turakhia |
| Designation |
|
| Affiliation |
|
| Address |
Bharat Serums & Vaccines Ltd, 1st Floor, Building No.1, Business Development Centre
Near Tatwagyan Vidyapeeth Ghodbunder Road
Thane
MAHARASHTRA
400610
India |
| Phone |
+91-22-61383409 |
| Fax |
+91-22-61383400 +91-22-61383400 +91-22-61383400 |
| Email |
naju.t@bharatserums.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bharat Serums and Vaccines Ltd |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Anil Agarwal |
Department of Gastrointestinal Surgery,G B Panth Hospital |
,-110002
New Delhi
DELHI |
09718599251
aka.gis@gmail.com |
| Dr. Meena Kumar |
B Y L Nair Charitable Hospital and T N Medical College |
Mumbai Central,-400008
Mumbai
MAHARASHTRA |
09820319129
meenavkumar@rediffmail.com |
| Dr. Anita Basavraj |
Department of Gastroenterology, B J Medical College and Sasoon Hospital |
Near Pune Railway Station,-411 001
Pune
MAHARASHTRA |
09423576044
anita.basavraj@rediffmail.com |
| Dr. Shobna Bhatia |
Department of Gastroenterology, Seth G.S. Medical College & K.E.M. Hospital |
Parel,-400012
Mumbai
MAHARASHTRA |
09869072213
sjb@kem.edu |
| Dr B Prabhakar |
Department of Gastroenterology,Osmania Medical College and General Hospital |
Department of Gastroenterology,Osmania Medical College and General Hospital, Afzalgunj, Hyderabad - 12
Hyderabad
ANDHRA PRADESH |
40-24606687
bprabhakardr@gmail.com |
| Dr. Asha Shah |
Department of Medicine, B J Medical College and Civil Hospital |
Asarwa,-380 016
Ahmadabad
GUJARAT |
9327066349
navneetasha@yahoo.com |
| Dr. Nivedita Moulick |
Department of Medicine, LTMMC & LTMG Hospital |
Sion,-400022
Mumbai
MAHARASHTRA |
09323609966
ndmoulick@rediffmail.com |
| Dr. S T Malhan |
Department of Medicine, V.S General Hospital |
Ellis Bridge,-380 006
Ahmadabad
GUJARAT |
09998335465
stmalhan@yahoo.co.in |
| Dr. Aparna Deshpande |
Department of Surgery , Seth G.S. Medical College & K.E.M. Hospital |
Parel,-400012
Mumbai
MAHARASHTRA |
09820231568
draparnadeshpande@yahoo.com |
| Dr. Satish Dharap |
Department of Surgery, LTMMC & LTMG Hospital |
Sion,-400022
Mumbai
MAHARASHTRA |
09869042629
drdharap@hotmail.com |
| Dr Jude Rodrigues |
Department of Surgery,Goa Medical College |
Department of Surgery,Goa Medical College,Bambolim, Goa – 403521
North Goa
GOA |
0832-2458700
rodriguesjude@hotmail.com |
| Dr. U C Biswal |
Dr. Ram Manohar Lohia Hospital |
Baba Kharak Singh Marg,Connaught Place-110 001
New Delhi
DELHI |
09818479091
ucbiswal@gmail.com |
| Dr. Neelima Chafekar |
N.D.M.V.P. Samaj Medical College |
Vasantdada Nagar,Adgaon-422003
|
09822408336
neelimachafekar@yahoo.com |
| Dr. P.K. Verma |
V.M.Medical College and Safdarjung Hospital |
AIIMS Crossing,-110029
New Delhi
DELHI |
09818402209
prateekverma88@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethics Committee- Goa Medical College |
Approved |
| Ethics Committee - LTMMC & LTMG Hospital |
Approved |
| Ethics Committee - B J Medical College and Civil Hospital |
Approved |
| Ethics Committee - B J Medical College And Sasoon Hospital |
Approved |
| Ethics Committee - B Y L Nair Charitable Hospital And T N Medical Colleg |
Approved |
| Ethics Committee - Dr. Ram Manohar Lohia Hospital |
Approved |
| Ethics Committee - Ethics Committee - G B Panth Hospital |
Approved |
| Ethics Committee - N.D.M.V.P. Samaj Medical College |
Approved |
| Ethics Committee - V. S General Hospital |
Approved |
| Ethics Committee - V.M.Medical College and Safdarjung Hospital |
Approved |
| Ethics Committee- LTMMC & LTMG Hospital |
Approved |
| Ethics Committee- Seth G.S. Medical College & K.E.M. Hospital |
Approved |
| Ethics Committee-Osmania Medical College and General Hospital |
Approved |
| Ethics Committee-Seth G.S. Medical college & K.E.M. Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K85||Acute pancreatitis, Mild or Severe Acute Pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Mild Acute Pancreatitis - B.D X 3days Severe Acute Pancreatitis -B.D X 5 days |
| Intervention |
Ulinastatin |
Mild acute pancreatitis -100000 IU B.D X 3days
Severe acute pancreatitis -100000 IU B.D X 5days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
I. Age >18years <70years (both inclusive)
II. Any two of the following three should be present:
1. Abdominal pain characteristic of acute pancreatitis
2. Serum amylase and/or lipase ≥ 3 times the upper
limit of normal
3. Characteristic findings of acute pancreatitis on USG, contrast-enhanced CT or MRI
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy or breast-feeding
2. Evidence of chronic pancreatitis on imaging
(calcification, ductal irregularity or dilatation)
3. Subjects requiring immediate surgery
4. Moribund state in which death was perceived to be
imminent ( ≤ 24 hours)
5. Participation in another investigational study within
30 days before the current study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum CRP Levels |
Day 0,3,5,7,12,22 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
Up to Day 22 or Discharge whichever is earlier |
| Length Of Hospital Stay (Days)In Survivors. |
Up To Day 22 Or Discharge Whichever Is Earlier |
| Complications, Including New Onset Organ Failure |
Up To Day 22 Or Discharge Whichever Is Earlier |
|
Target Sample Size
Modification(s)
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
30/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Efficacy and safety of intravenous ulinastatin versus placebo along with standard supportive care in subjects with mild or severe acute pancreatitis. J Assoc Physicians India. 2013 Aug;61(8):535-8. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a randomised, placebo controlled, double-blind study to determine the efficacy and safety of Ulinastatin as adjuvant therapy in treatment of Mild or Severe Acute Pancreatitis. Ulinastatin (100000IU)/ Placebo will be given b.d. for 3 days for mild acute pancreatitis and 5 days for severe acute pancreatitis . The primary outcome measure is Number of days for Serum CRP levels to normalize and secondary outcome measures are Mortality, Average length of hospital stay (days) till discharge in survivors and Complications including new onset organ failure. This study will be conducted in twelve centers in India. |