Specific aims: Determining the rate of HP eradication of two 14-day reverse hybrid regimes and 14-day concomitant regimens and comparing the rate of eradication of the two above regimens.
hypothesis: The effectiveness of the 14-days reversed hybrid regimen in Helicobacter pylori eradication is close to that of the 14-days concomitant regimens. Compliance of patients with drug use is better in reversible hybrid groups and with fewer side effects than concomitant regimens.In this randomized clinical trial, a total of 260 patients with dyspepsia enrolled the study. endoscopic evaluation was done and have indication for helicobacter pylori eradication. this patients dont received HP eradication regimens Previously . all patients entered the study in two groups.
Patients are randomly assigned to two subgroups. In Group A (reverse hybrid group): patients in the first 7 days of treatment receive pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500 mg, metronidazole 500 mg every 12 hours, and the second 7 days, clarithromycin and metronidazole were interrupted and only Pentoprazole and amoxicillin are continued at the same dose. Group B (14 days concomitant group): four drugs: pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500 mg and metronidazole 500 mg every 12 hours for 14 days prescribed. The results of the study are then analyzed statistically
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081215510N3
Registration date:2017-09-24, 1396/07/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-24, 1396/07/02
Registrant information
Name
Seyed Mohammad Valizadeh Toosi
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 2242
Email address
sm.valizadehtoosi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
The financial source of the study is through the Deputy of Technology of Mazandaran University of Medical Sciences.
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Efficacy of14 days Reverse Hybrid Regimen and 14 days concomitant Therapy for HP eradication
Public title
Comparing the Efficacy of14 days Reverse Hybrid Regimen and 14 days concomitant Therapy for HP eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with endoscopic findings of gastric or duodenal ulcer or gastric and duodenal erosoin and have Helicobacter pylori infection ; patients older than 18 year and less than 80 years. Exclusion criteria : pregnancy and lactation ; previously received Helicobacter pylori therapy ; patients received PPI (poroton poup inhibitor) or H2 RA (histamine 2 receptor antagonist) in last 2 weeks or within 4 weeks who received antibiotics ; history of surgery on the stomach ; Patients with confirmed advanced disease , severe cardiac, pulmonary , endocrine , chronic renal failure, chronic liver disease or have cancer ; The consumption of alcoholic beverages
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
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
Technology deputy, Mazandaran University Of Medical Sciences
Street address
Moallem Squre
City
Sari
Postal code
324776119
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1396.2982
Health conditions studied
1
Description of health condition studied
Gastric Ucer
ICD-10 code
K25
ICD-10 code description
gastric ulcer
Primary outcomes
1
Description
Helicobacter pylori infection
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Upper GI endoscopy and biopsy for pathology and RUT for HP infection before intervention and endoscopy and biopsy or urea breath test and or stool examination for HP antigen for HP infection after intervention
Secondary outcomes
1
Description
HP eradication rate and drug adverse effects and patients compliance in two groups
Timepoint
12 weeks after initiation of therapautic regimens
Method of measurement
Urea breath test, stool exam for HP antigen and or endoscopy and biopsy. questionary assesment
Intervention groups
1
Description
In intervention group (reverse hybrid group): patients in the first 7 days of treatment receive pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500 mg, metronidazole 500 mg every 12 hours, and the second 7 days, clarithromycin and metronidazole were interrupted and only Pentoprazole and amoxicillin are continued at the same dose.
Category
Treatment - Drugs
2
Description
In control group: (14 days concomitant group): four drugs: pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500 mg and metronidazole 500 mg every 12 hours for 14 days prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Subspecialty of Toba clinic, Sari Emam Khomeni Hospital Endoscopy Ward
Full name of responsible person
DR Seyed Mohammad Valizadeh Toosi
Street address
Khazar Blvd.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Technology Assistant, Mazandaran University Of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Technology Assistant, Mazandaran 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
Gut and Liver research Center, Mazandaran University Of Medical Sciences
Full name of responsible person
Seyed Mohammad Valizadeh Toosi
Position
Assitant Professor of Gastroenterology, Gastroenterologist
Other areas of specialty/work
Street address
Imam Khomeni Hospital
City
Sari
Postal code
481666-33131
Phone
+98 11 3337 7176
Fax
+98 11 3337 7176
Email
gutliver@yahoo.com
Web page address
htpp://http://ugii.mazums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gut and Liver research Center, Mazandaran University Of Medical Sciences