This study is aimed to compare clinical effectiveness of oral omeprazole and intravenous infusion of pantaprazole in prevention of peptic ulcers rebleeding. INCLUSION CRITERIA :Patients who refer to hospital due to hematemesis ,melena and hematochesia .EXCLUSION CRITERIA :patients who have history of liver cirrhosis, GI malignancy uremia or bleeding tendency .83 enrolled patients randomly allocate to receive either oral omeprazole (OMP group ,40 mg twice daily for 3 days ) or i.v. pantaprazole ( PAN group ,80 mg stat then 8mg each hour for 72 or 48 hour) .All patient evaluate endoscopically and endoscopic intervention would take if neccesary . Subsequently the enrolled patients will receive oral omeprazole 20 mg daily for 14 days .The primary end point is in hospital recurrent bleeding , surgery or mortality. m.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711191650N1
Registration date:2010-01-03, 1388/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-03, 1388/10/13
Registrant information
Name
Seyed Alireza Hashemi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83233170098711
Email address
hashemiar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research departement -Shiraz University of Medical Science
Expected recruitment start date
2008-11-20, 1387/08/30
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of oral omeprazole versus intravenous pantaprazole in peptic ulcer bleeding
Public title
Comparing effect of oral omeprazole versus intravenous pantaprazole in peptic ulcer bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
INCLUSION CRITERIA ;All patient who admite in hospital due to GI bleeding and have high risk ulcer in endoscopic evaluation.
EXCLUSION CRITERIA ;Any patient who find to have esophageal varices ,bleeding tendency ,GI cancer ,uremia or Mallory Weiss tear.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Departement -Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences -Zand avenue -Shiraz -Iran
City
Shiraz
Postal code
Approval date
empty
Ethics committee reference number
CT-87-4431
Health conditions studied
1
Description of health condition studied
Peptic ulcer, bleeding
ICD-10 code
K-27.0
ICD-10 code description
Peptic ulcer, site unspecified
Primary outcomes
1
Description
recurrent bleeding
Timepoint
daily up to discharge and after 14 days
Method of measurement
hypotension,tachucardia ,Hb drop ,hematemesis after stabilization and recurrence of melena after normal stool
2
Description
surgery
Timepoint
daily up to discharge and after 14 days
Method of measurement
daily up to discharge and phone call after 2 weeks
3
Description
mortality (All cause )
Timepoint
daily up to discharge
Method of measurement
daily up to discharge and phone call after 2 weeks
Secondary outcomes
1
Description
blood transfusion
Timepoint
during discharge
Method of measurement
number of transfused blood packed cells
2
Description
hospital stay
Timepoint
daily
Method of measurement
assess during discharge
Intervention groups
1
Description
All patients who admit in odd days will take oral omeprazole (40 mg po BID ) and then 20 mg omeprazole daily up to 14 days.All patient will evaluate endoscopically and endoscopic intervention would be done if need.
Category
Treatment - Drugs
2
Description
patients who will admit in even days will recieve pantoprazole ( 8 mg / hour ) for 72 or 48 hour and then take omeprazole 20 mg daily up to 14 days .
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazi and shahid-faghihi hospitals
Full name of responsible person
Seyed Alireza Hashemi
Street address
koocheh 2 -Poostchi avenue-Shiraz -Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mostaghni .Amir Ahmad
Street address
Internal Ward -Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Alireza Hashemi
Position
Gastroentrology assistant
Other areas of specialty/work
Street address
City
Shiraz
Postal code
00987184966555
Phone
+98 71 1832 3317
Fax
Email
hashemiar@sums.ac.ir hashemiar116@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Amir Ahmad Mostaghni
Position
Assistant professor in gastroentrology
Other areas of specialty/work
Street address
koocheh 2 -Poostchi avenue-Shiraz -Iran
City
Shiraz
Postal code
Phone
+98 71 1234 1175
Fax
Email
mostaghnia@sums.ac.ir amost44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Alireza Hashemi
Position
Gastroentrology Assistant
Other areas of specialty/work
Street address
No 394 -66/9 -Pasdaran Avenue-Shiraz -Iran
City
Shiraz
Postal code
Phone
+98 71 1832 3317
Fax
Email
hashemiar@sums.ac.ir hashemi116@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)