Effect of three-drug regimen against H. pylori infection versus four-drug regiment in patients with dyspepsia or peptic ulcer disease: a randomized clinical trial
Objectives: To assess the effect of three-drug regimen against H. pylori infection versus four-drug regiment in patients with dyspepsia or peptic ulcer disease.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with dyspepsia or peptic ulcer disease who will refer to Shahid Behashti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: dyspepsia for at least 3 months; H. pylori infection, age of 18 to 70 years.
Exclusion criteria: pregnancy or breastfeeding; history of surgery of upper stomach or bowel; gastric cancer; renal or lever failure.
Intervention group 1: Capsule Omeprazole 20 mg twice a day and capsule Amoxicillin 1000 mg twice a day and capsule clarithromycin 500 mg twice a day for 14 days.
Intervention group 2: Capsule Omeprazole 20 mg twice a day and capsule Amoxicillin 1000 mg twice a day and capsule Levofloxacin 500 mg twice a day for 14 days.
Control group: Capsule Omeprazole 20 mg twice a day and capsule Amoxicillin 1000 mg twice a day and tablet Metronidazole 500 mg twice a day and tablet Bismuth 240 mg twice a day for14 days.
Primary outcome: Assessing the irradiation of H. pylori infection 4 to 6 weeks after treatment using urease respiratory test with labeled carbon.
Secondary outcome: Nothing.
Randomization: The patients will be randomly assigned to intervention and control groups using random number table.
Blinding: Not blinded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605189014N100
Registration date:2016-06-08, 1395/03/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-08, 1395/03/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of three-drug regimen against H. pylori infection versus four-drug regiment in patients with dyspepsia or peptic ulcer disease: a randomized clinical trial
Public title
Effect of three-drug regimen against H. pylori infection versus four-drug regiment in patients with dyspepsia or peptic ulcer disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: dyspepsia for at least 3 months; H. pylori infection, age of 18 to 70 years.
Exclusion criteria: pregnancy or breastfeeding; history of surgery of upper stomach or bowel; gastric cancer; renal or lever failure.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using random number table.
Blinding: Not blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.UMSHA.REC.1394.445
Health conditions studied
1
Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Dyspepsia
Primary outcomes
1
Description
Assessing the irradiation of H. pylori infection
Timepoint
4 to 6 weeks after treatment
Method of measurement
using urease respiratory test with labeled carbon
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Intervention group 1: Capsule Omeprazole 20 mg twice a day and capsule Amoxicillin 1000 mg twice a day and capsule clarithromycin 500 mg twice a day for 14 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: Capsule Omeprazole 20 mg twice a day and capsule Amoxicillin 1000 mg twice a day and capsule Levofloxacin 500 mg twice a day for 14 days.
Category
Treatment - Drugs
3
Description
Control group: Capsule Omeprazole 20 mg twice a day and capsule Amoxicillin 1000 mg twice a day and tablet Metronidazole 500 mg twice a day and tablet Bismuth 240 mg twice a day for14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Anvar Bahrami
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Shahid Beheshti Hospital
Full name of responsible person
Dr Anvar Bahrami
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
med5921@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Maryam Hasan Zarini
Position
Internist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
mhzarrini@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)