This study will be done with aim to investigate the effectiveness of Pantoprazole in the increase of Asacol absorption to treatment of inflammatory bowel disease. This study is a single blind clinical trial. The study population will include patients with inflammatory bowel disease (IBD) referred to Imam Reza Hospital in Kermanshah city. The number of 30 eligible patients will be selected and will be assigned in a experimental group of 30 people. The baseline, frequency of defecation and excretion of blood in the feces and drug excretion in the feces will be asked from patients then addition to the routine Asacol, Pantoprazole (40 g once per day) administered for two weeks. After taking the drug for two weeks, frequency of defecation and excretion of blood in the feces and
drug excretion in the feces will asked from patients again and will be recorded in the Checklist and changes in the experimental group before and after administration of the drug will be compared.
Inclusion criteria: Age between 17 to 70 years; Patients who are taking Asacol medicine tablets (400 g); Patients who have a history of drug excretion.
Exclusion criteria: Patients with a history of underlying disease and hypertension drug users; Patients who are contraindicated for Asacol
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012227761N3
Registration date:2017-02-05, 1395/11/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-05, 1395/11/17
Registrant information
Name
homayoon bashiri
Name of organization / entity
kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6310
Email address
h.bashiri@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness and non effectiveness of Pantoprazole in the increase of Asacol absorption to treatment of inflammatory bowel disease
Public title
Effect of Pantoprazole on Asacol absorption in patients with Inflammatory Bowel Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 17 to 70 years; Patients who are taking Asacol medicine tablets (400 g); Patients who have a history of drug excretion.
Exclusion criteria: Patients with a history of underlying disease and hypertension drug users; Patients who are contraindicated for Asacol
Age
From 17 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
kums.rec.1394.31
Health conditions studied
1
Description of health condition studied
Inflammatory bowel disease
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Asacol absorption
Timepoint
Baseline, the end of the study (two weeks after drug administration)
Method of measurement
Based on Checklist
Secondary outcomes
empty
Intervention groups
1
Description
In experimental group addition to the routine Asacol, Pantoprazole (40 g once per day) administered for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Sara Ghadimi noran
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Ghadimi noran
Position
Resident of Internal
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
s.ghadimi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Homayoon Bashiri
Position
Gastroenterologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
hbashirimd@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Ghadimi noran
Position
Resident of Internal
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
s.ghadimi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)