aims: Comparing clarithromycin-based triple therapy Helicobacter pylori eradication with triple therapy containing levofloxacin
Inclusion criteria:All patients underwent endoscopy with duodenal ulcer or gastric or duodenal or stomach inflammation and Erosoin Sari hospital clinic professor Gu reported that Helicobacter pylori positive and study are older than 18 years
Exit key criteria: During the last two weeks, patients with PPI or H2 RA (histamine 2 receptor antagonist), or within the last 4 weeks have received antibiotics or bismuth; Concomitant use of anticoagulants ;corticosteroids or ketoconazole; Patients with a history of stomach surgery; Patients with peptic ulcer bleeding complication refer and endoscopy used to control bleeding
Sample: 120
Intervention and time: Patients with duodenal ulcer or gastric or duodenal or stomach inflammation and erosion after endoscopic diagnosis of Helicobacter pylori positive test randomly placed in two groups A and B ,Patients with duodenal ulcer or gastric or duodenal or stomach inflammation and erosion after endoscopic diagnosis of Helicobacter pylori positive test randomly placed in two groups A and B
Patients through random table into randomly receive one of the two regimes.
A:pantoprazole 40mg/bd-Amoxicilin1g/-Clarithromycin500/bd
B:pantoprazole 40mg/bd-Amoxicilin1g/-levofloxacine500/dailyto 10days
inclusion criteria: All patients underwent endoscopy with duodenal ulcer or gastric or duodenal or stomach inflammation and Erosion referred to the clinic / office professor interviewed Sari hospital reported that Helicobacter pylori positive and study are older than 18 years
Exclusion criteria: Pregnancy and breastfeeding; H. pylori eradication has already been received; During the last two weeks patients with PPI or H2 RA (histamine 2 receptor antagonist), or within the last 4 weeks have received antibiotics or bismuth; Concomitant use of anticoagulants; corticosteroids or ketoconazole; Patients with a history of stomach surgery; Patients with advanced disease confirmed and severe cardiac; pulmonary;Endocrine; chronic renal failure; chronic liver disease and cancer; alcohol consumption; With a history of peptic ulcer bleeding ulcer complications
Age
From 76 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Mazandaran University Of Medical Sciences-Department of Research and Technology
Street address
Mazandaran,Sar,Moalem Street,Department of Research and Technology
City
Sari
Postal code
4817844718
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.MAZUMS.REC.94-1880
Health conditions studied
1
Description of health condition studied
Eradication of Helicobacter pylori
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Eradication of Helicobacter pylor
Timepoint
10 days after treatment,4 Weeks after treatment ppI,Four weeks after discontinuation of medication for respiratory test
Method of measurement
Through the breath test 14 C- UBT
Secondary outcomes
1
Description
Headache،Dizziness،Confusion
Timepoint
During the course of treatment
Method of measurement
Calling and patient interview
2
Description
Bitter mouth
Timepoint
During the course of treatment
Method of measurement
Calling and patient interview
3
Description
Diarrhea-vomiting
Timepoint
During the course of treatment
Method of measurement
Calling and patient interview
4
Description
Skin complications
Timepoint
During the course of treatment
Method of measurement
Calling and patient interview
5
Description
Nausea , abdominal pain
Timepoint
During the course of treatment
Method of measurement
Calling and patient interview
6
Description
Side effects reported by patients include hypersensitivity reactions
Timepoint
During the course of treatment
Method of measurement
Calling and patient interview
7
Description
Constipation Decreased appetite
Timepoint
During the course of treatment
Method of measurement
Calling and patient interview
8
Description
Changes in taste
Timepoint
During the course of treatment
Method of measurement
Calling and patient interview
Intervention groups
1
Description
Control group: Panto Prazol 40 mg twice daily , amoxicillin 1g , clarithromycin 500 mg twice daily for 10 days
Category
Treatment - Drugs
2
Description
Groups intervention: pantoprazole 40 mg twice daily, amoxicillin 1 g, levofloxacin 500 mg once daily for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Mr.Dr Fakheri
Full name of responsible person
Mr Fakheri
Street address
Mazandaran,Sari,Street Qarn,Clinic Mr .Dr Fakheri
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of medical sciences,Deputy of Research and Technology
Full name of responsible person
Mr. Dr. Enayati
Street address
Mazandaran,Sari,Moalem street,Deputy of Rresearch and Technology
City
Sari
Grant name
IR.MAZUMS.REC.94-1880
Grant code / Reference number
۱۸۸۰
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of medical sciences,Deputy of Research and Technology
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
Mazandaran University of Medical Sciences,Deputy of Research and Technology
Full name of responsible person
Mr. Dr Fakheri
Position
Gastroenterologist,Professor and Facultyof Medica lMazandaran University
Other areas of specialty/work
Street address
Mazandaran,sari,Moallem Street,Deputy of Research and Technology
City
Sari
Postal code
4817844718
Phone
+98 11332612468
Fax
Email
GI-research-1@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences,Deputy of Research and Technology University
Full name of responsible person
Mr .Dr Fakheri
Position
Profossor
Other areas of specialty/work
Street address
Deputy of Research and Technology University
City
Sari
Postal code
4817844718
Phone
+98 11332612468
Fax
Email
GI-research-1@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences,Deputy of Research and Technology University
Full name of responsible person
ِDr.Fakheri
Position
Gastroenterologist
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences,Deputy of Research and Technology University
City
Sari
Postal code
4817844718
Phone
+98 11332612468
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)