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The comparison of quinolone-based regimen and conventional quadruple therapy in patients with H.pylori infection

Protocol summary

Summary
H. pylori infection can result to diseases such as peptic ulcer, gastritis, gastric cancer and mucosa-associated lymphoid tissue lymphoma of the stomach. Therefore, its eradication is essential to control these clinical conditions. However, resistance to antibiotics can reduce the eradication success up to 70%.When several attempts to eradicate H.pylori fails, a quinolone such as levofloxacin can be used. Gemifloxacin is a new quinolone that has a much lower MIC than other drugs in this category. So, we conducted a randomized , non-placebo-controlled, multicenter, phase III trial to compare the eradication rate of H.pylori between regular regimen and Gemifloxacin -containing regimen. In this study 140 patients with gastrointestinal discomfort will be evaluated for H. pylori infection, and patients that use antibiotics, bismuth salts or non-steroidal anti-inflammatory drugs during the previous 4 weeks, or had previous gastric surgery, severe systemic diseases, pregnancy and breastfeeding will be excluded. The intervention will take place over a 2-week regimen. Then eradication rate will be compared between groups based on their UBT results.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012101311101N1
Registration date: 2012-11-30, 1391/09/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-30, 1391/09/10
Registrant information
Name
Mehrdad Sedigh Ardekani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 3733
Email address
sharif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shiraz University of Medical Sciences, Professor Alborzi Research Center Shiraz University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of quinolone-based regimen and conventional quadruple therapy in patients with H.pylori infection
Public title
The effect of quinolone-containing regimens for the treatment of Helicobacter pylori infection.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All adult patients with gastrointestinal discomfort who refer to Namazi Hospital, Shiraz University of Medical Sciences. Exclusion criteria: Previous history of Helicobacter pylori eradication therapy; Consumption of antibiotics, bismuth salts or non-steroidal anti-inflammatory drugs during the past four weeks; previous gastric surgery; severe systemic diseases (such as liver cirrhosis or renal failure); sensitivity to each the antibiotics used in classical therapy; pregnancy and breastfeeding.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Shiraz University of Medical Sciences
Street address
Shiiraz University of Medical Sciences central building, Zand avenue
City
Shiraz
Postal code
Approval date
2012-08-30, 1391/06/09
Ethics committee reference number
CT-91-4703

Health conditions studied

1

Description of health condition studied
Helicobacter pylori infection
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
cure rate
Timepoint
1 month after completion of drug therapy
Method of measurement
Urea Breath Test

Secondary outcomes

1

Description
adverse drug reactions
Timepoint
after 2 weeks drug therapy
Method of measurement
patient evaluation

Intervention groups

1

Description
Gemifloxacin,Oral tablet 320 mg, once daily, for 2 weeks
Category
Treatment - Drugs

2

Description
Metronidazol,250 mg, two tablets every 12 hours, for 2 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Street address
Namazi Hospital, Namazi Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali Poostforoosh
Street address
Shiraz University of Medical Sciences central building, Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Laleh Mahmoudi
Position
Assistant professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Shiraz Faculty of Pharmacy
City
Shiraz
Postal code
Phone
+98 71 1242 4127
Fax
Email
mahmoudi_l@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Laleh Mahmoudi
Position
Assistant professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Shiraz Faculty of Pharmacy
City
Shiraz
Postal code
Phone
+98 71 1242 4127
Fax
Email
mahmoudi_l@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Sedigh Ardekani
Position
student
Other areas of specialty/work
Street address
City
Shiraz
Postal code
7135737114
Phone
+98 71 1235 3733
Fax
Email
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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