The purpose of this study was to compare the effects of several proton pump inhibitors (including omeprazole, pantoprazole, osoperazole and lansoprazole) on the symptoms of patients with Gastroesophageal Reflux Disease.
Design
This study is a randomized clinical trial (open-label), and the study was conducted for a period of 6 months.
The sample size is determined using previous studies in Iran and statistical formulas . 30 persons in each intervention group are considered.
Patients are randomly divided into four groups
Settings and conduct
The places for the study are Gastroenterology and Internal clinics of Isfahan province.Patients symptoms including HeartBurn and Acid Regurgitation will be measured in 0,2,4,8 week of treatment via questionnaire
Participants/Inclusion and exclusion criteria
Inclusion Criteria: patients with major symptoms of reflux disease ie HeartBurn and Acid Regurgitation that have two or more episodes of symptoms per week
Exclusion Criteria :History of Cancer,Odinophagia,Dysphagia,Recent weight loss
Intervention groups
Group1 Opeprazole 40mg (OMP)-Manufactured by Abidi Pharma-Iran
Gruop 2 Pantoperazole 40mg (PAN)-Manufactured by Abidi Pharma-Iran
Group3 Esomeprazole 40mg (ESO)-Manufactured by Abidi Pharma-Iran
Group4 Lansoprazole 30mg(LAN)-Manufactured by Abidi Pharma-Iran
All drugs were administered daily for eight weeks
Main outcome variables
After 8 weeks of treatment, patients are evaluated for the chronic reflux symptoms and Satisfaction with the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036616N1
Registration date:2018-10-01, 1397/07/09
Registration timing:retrospective
Last update:2018-10-01, 1397/07/09
Update count:0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3653 2021
Email address
qoghnus@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-07-22, 1397/04/31
Trial completion date
2018-07-22, 1397/04/31
Scientific title
Comparison of The effect of Omeprazole,Pantoprazole,Esomeprazole and Lansoprazole on the Symptoms in Patients with Gastroesophageal Reflux Disease
Public title
Comparison of the Effect of Omeprazole,Pantoprazole,Esomeprazole and Lansoprazole on the Patients with Gastroesophageal Reflux Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Gastroesophageal Reflux Disease with frequent symptoms(2 or more symptoms per week)
Exclusion criteria:
Weight Loss
History of cancer
Odinophagia
Dysphagia
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple:
Patients were randomized in each of the four interventional groups by using Table of Random Digits. Patients who were excluded from the project for any reason were replaced by new patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan Medical University
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81774673461
Approval date
2017-05-30, 1396/03/09
Ethics committee reference number
IR.MUI.REC.1396.3.343
Health conditions studied
1
Description of health condition studied
Gastro-oesophageal Reflux Disease
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
Heart Burn
Timepoint
0 , 2 , 4 , 8 weeks
Method of measurement
questionnaire
2
Description
Acid Regurgitation
Timepoint
0 , 2 , 4 , 8 weeks
Method of measurement
questionnaire
Secondary outcomes
1
Description
Total Satisfaction
Timepoint
0,2,4,8 week
Method of measurement
Questionnaire
Intervention groups
1
Description
omeprazole 40mg daily(the pateint will consume two 20mg omeperazole capsules on fasting every morning for 8 weeks)
Category
Treatment - Drugs
2
Description
Pantoprazole 40mg daily(the pateint will consume one 40mg Pantoprazole capsule on fasting every morning for 8 weeks)
Category
Treatment - Drugs
3
Description
Esomeprazole 40mg daily(the pateint will consume one 40mg Esomeprazole capsule on fasting every morning for 8 weeks)
Category
Treatment - Drugs
4
Description
Lansoprazole 30mg daily(the pateint will consume one 30mg Lansoprazole capsule on fasting every morning for 8 weeks)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Azzahra Hospital GastroIntestinal Clinic
Full name of responsible person
Nima Arezoomandi
Street address
Soffeh
City
Isfahan
Province
Isfehan
Postal code
8175887573
Phone
+98 31 3620 2020
Email
qoghnus@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abidi Pharma
Full name of responsible person
Marzieh Jafari
Street address
Bokharest Ave.
City
Tehran
Province
Tehran
Postal code
1513815811
Phone
+98 21 8870 1600
Email
m.jafari@cobeldarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abidi Pharma
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nima Arezoomandi
Position
Resident of Internal Medicine
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hakim Nezami
City
Isfahan
Province
Isfehan
Postal code
8175887573
Phone
+98 316532021
Email
qoghnus@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nima Arezoomandi
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hakim Nezami
City
Isfahan
Province
Isfehan
Postal code
8175887573
Phone
+98 31 3653 2021
Email
qoghnus@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nima Arezoomandi
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hakim Nezami
City
Isfahan
Province
Isfehan
Postal code
8175887573
Phone
+98 31 3653 2021
Email
qoghnus@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Questionnaire
Informed consent form
Outcomes
When the data will become available and for how long
6 month after publishing
To whom data/document is available
Any researcher
Under which criteria data/document could be used
Any Reseacher
From where data/document is obtainable
Nima Arezoomandi,Email
What processes are involved for a request to access data/document