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Comparison of helicobacter pylori eradication of fourteen days regimen of four medications “bismuthe subcirate, pantoprazole, amoxicilline, clarithromycin” with seven days sequential regimen of “bismuthe subcirate, pantoprazole, amoxicilline, meteronidazole” and “bismuthe subcirate, pantoprazole, amoxicilline, furazolidone”

Protocol summary

Summary
We decided to compare a routine regimen with a sequential one. This study is the third phase of a double blind clinical trial, which would be done in a 6 months period during the year of 1396. 344 persons were chosen random block in a specific time period from the people referred to the endoscopy department, which had a positive helicobacter pylori endoscopic report. They were divided into two 172 groups, one group treated with the 14 days regimen of “bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, clarithromycin 500 mg twice a day made by Actover , and the sequential regimen; first 7 days of bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, meteronidazole 500 mg twice a day made by abidi, and second 7 days with bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, and furazolidone 100 mg twice a day made by Tehran Darou). An UBT with carbon 14 would be done 4 weeks after the end of the treatment to find out the efficacy of the therapeutic regimens. In addition, we would evaluate the side effects 2 weeks after the initiation of the treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201708071155N26
Registration date: 2017-08-08, 1396/05/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-08, 1396/05/17
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Guilan Univercity of Medical Sciences
Expected recruitment start date
2017-07-13, 1396/04/22
Expected recruitment end date
2018-01-12, 1396/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of helicobacter pylori eradication of fourteen days regimen of four medications “bismuthe subcirate, pantoprazole, amoxicilline, clarithromycin” with seven days sequential regimen of “bismuthe subcirate, pantoprazole, amoxicilline, meteronidazole” and “bismuthe subcirate, pantoprazole, amoxicilline, furazolidone”
Public title
The effect of fourteen days regimen of four medications “bismuthe subcirate, pantoprazole, amoxicilline, clarithromycin” and seven days sequential regimen of “bismuthe subcirate, pantoprazole, amoxicilline, meteronidazole” and “bismuthe subcirate, pantoprazole, amoxicilline, furazolidone” in helicobacter pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
• Inclusion criteria: Positive helicobacter pylori in the endoscopy and no therapeutic regimen for treatment • Exclusion criteria: Pregnant and breast feeding women, gastric and esophageal malignancy, cirrhosis, heart and kidney failure, history of seizure, hematologic diseases, and allergy to medications, patients with incomplete treatment period, severe side effects, and no satisfaction to continue treatment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 344
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No Comment

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences.
Street address
Gaz square ,Shaheed Beheshti street,Research and Technology Deputy Rasht, Iran
City
Rasht
Postal code
4193893345
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.GUMS.REC.1396.141

Health conditions studied

1

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 eradication
Timepoint
12 weeks
Method of measurement
Ureas Breath Test with C14

Secondary outcomes

1

Description
Comparison of helicobacter pylori eradication of fourteen days regimen of four medications “bismuthe subcirate, pantoprazole, amoxicilline, clarithromycin” with seven days sequential regimen of “bismuthe subcirate, pantoprazole, amoxicilline, meteronidazole” and “bismuthe subcirate, pantoprazole, amoxicilline, furazolidone”
Timepoint
2-4 weeks
Method of measurement
2-4 weeks

Intervention groups

1

Description
Intervention group takethe 14 days treatment of bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, clarithromycin 500 mg twice a day made by Actover , and the sequential regimen; first 7 days of bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, meteronidazole 500 mg twice a day made by abidi, and second 7 days with bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, and furazolidone 100 mg twice a day made by Tehran Darou.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Fariborz Mansour ghanaei
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan Univercity of Medical Sciences
Full name of responsible person
Dr.Mir saeed attarchi
Street address
Sadati st, Samjoo st, Rasht,Guilan
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan Univercity 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
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Farahnaz Joukar
Position
Deputy of Gastrointestinal and Liver Diseases Research Center
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht
City
Rasht
Postal code
955655-41448
Phone
+98 13 3353 5116
Fax
Email
farajov@gmail.com
Web page address
www.gldrc.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Position
Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
95655-41448
Phone
+98 13 3353 5116
Fax
Email
ghanaie@yahoo.com
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Mehrnaz Asgharnezhad
Position
Master Of Nursing
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
955655-41448
Phone
+98 13 3353 5116
Fax
Email
asgharnezhad98@yahoo.com
Web page address
www.gldrc.org

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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