Protocol summary

Summary
This study is a prospective and randomized double-blind clinical trial. The aim of this study is comparison of standard triple therapy with sequential therapy with base of levofloxacinand tinidazole in eradication of helicobacter pylori in patients with duodenal ulcer. Total of sample size is 168 patient with ages: 20-70 years old. The patients with a history of treatment of Helicobacter pylori, taking antibiotics, history of total gastrectomy, liver cirrhosis and uremia will be excluded. The patients are randomly divided into two groups with table of random numbers by computer. Assessor of results and patients do not know about the protocol of the study. First group, the first five days, receives pantoprazole, 40 mg twice daily, plus amoxicillin, 1 gm twice daily and the next five days receives pantoprazole, 40mg twice daily, levofloxacin 500 mg twice daily and tinidazole 500 mg twice daily. The second group as a control group receives omeprazole, 20 mg plus amoxicillin 1gr and clarithromycin 500 mg (All three drugs twice daily) for 10 days. Patients basic information such as age and sex, stature, Smoking, use of nonsteroidal antiinflammatory drug, alcohol intake, history of drug abuse will be recorded in both groups before treatment. Urea breath test results with c14 and endoscopy to check for Helicobacter pylori infection will be recorded in both groups before treatment and 8 week after completion of treatment period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110124823N1
Registration date: 2015-12-24, 1394/10/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
Shahram Hamedifar
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
hamedifar.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur
Expected recruitment start date
2015-10-18, 1394/07/26
Expected recruitment end date
2016-03-16, 1394/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of standard triple therapy with sequential therapy With base of levofloxacin and tinidazole in eradication of Helicobacter Pylori in patients with duodenal ulcer
Public title
The effect of taking antibiotic on treatment of Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with symptoms of dyspepsia, epigastric pain, nausea, vomiting, melena, hematemesis; Patients with duodenal ulcer; Patients with ages: 20-70. Exclusion Criteria: History of treatment of Helicobacter pylori; taking antibiotics; history of previous surgery on the stomach like total gastrectomy and gastrojejunostomy; history of drug allergies; liver cirrhosis; uremia; pregnancy.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 168
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Drug compliance and complications are checked every three days. Acceptable compliance is defined as taking at least 70% of prescribed drugs. Complications is classified as follows: None or mild (creation discomfort without interfering with life activities), moderate (moderate discomfort that causes interference in life but continue treatment) and severe (leading to drug discontinuation by the patient).

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.AJUMS.REC.1394.401

Health conditions studied

1

Description of health condition studied
Duodenal ulcer
ICD-10 code
K26
ICD-10 code description
erosion (acute) of duodenum, ulcer (peptic): duodenal-postpyloric

2

Description of health condition studied
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
Helicobacter pylori infection
Timepoint
Before treatment and 8 week after completion of treatment
Method of measurement
Urea breath test with C14

2

Description
Helicobacter pylori infection
Timepoint
Before treatment and 8 week after completion of treatment
Method of measurement
Endoscopy

Secondary outcomes

1

Description
Nausea and vomiting
Timepoint
Every three days during treatment period
Method of measurement
Verbal questionnaire and the patient's response

2

Description
Abdominal pain
Timepoint
Every three days during treatment period
Method of measurement
Verbal questionnaire and the patient's response

3

Description
Watery diarrhea
Timepoint
Every three days during treatment period
Method of measurement
Verbal questionnaire and the patient's response

4

Description
Secretion or vaginal itching
Timepoint
Every three days during treatment period
Method of measurement
Verbal questionnaire and the patient's response

Intervention groups

1

Description
Group I (Intervention group): Patients, the first five days, receives pantoprazole, 40 mg twice daily, plus amoxicillin, 1 gm twice daily and the next five days receives pantoprazole, 40mg twice daily and levofloxacin 500 mg twice daily and tinidazole 500 mg twice daily.
Category
Treatment - Drugs

2

Description
Group II (Control group): Pateints receives omeprazole, 20 mg plus amoxicillin 1gr and clarithromycin 500 mg (All three drugs twice daily) for 10 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khomeini Hospital
Full name of responsible person
Pezhman Alavinezhad
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahram Hamedifar
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
drshahramhamedifar@gmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Abdolrahim Masjedizadeh
Position
Subspeciality Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
-
Phone
+98 61 3222 2922
Fax
Email
rmasjedi@hotmail.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
-
Phone
+98 61 3222 2922
Fax
-
Email
s.nz1990@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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