Protocol summary

Summary
The main objective of this study is to compare the effectiveness of two sequential therapy regimens versus standard triple-drug therapy for eradication of Helicobacter Pylori in patients suffering from Dyspepsia. This study is a randomized, not blinded, single-center, not placebo controlled trial. 300 patients with Dyspepsia who have the positive Helicobacter Pylori infection based on pathological result, after performing upper endoscopy, will be enrolled in the study. Patients that need more treatments based on endoscopy results, patients with severe underlying diseases, pregnant and lactating women and patients who have allergies to drugs we want to use are excluded. These 300 patients will be randomly divided into 3 equal groups using random numbers table. Each group contains 100 patients that are the same according to age and gender. Drug regimen for these groups is as below. Group 1 (intervention): Sequential therapy with Omeprazole, Amoxicillin, Clarithromycin and Metronidazole. Group 2 (intervention): Sequential therapy with Omeprazole, Amoxicillin, Levofloxacin and Metronidazole. Group 3 (control): Standard triple therapy with Omeprazole, Amoxicillin and Clarithromycin. Patients will be visited after the completion of treatment course to be asked about side effects of drugs and 6 weeks after the treatment, they will be analyzed with Urea Breath Test (UBT). Helicobacter Pylori eradication is based on the negativity of Urea Breath Test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015082323736N1
Registration date: 2016-02-09, 1394/11/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-09, 1394/11/20
Registrant information
Name
Mosayeb Moradniani
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3333 6138
Email address
dr.m.morad@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Lorestan University of Medical Sciences
Expected recruitment start date
2016-01-05, 1394/10/15
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two Sequential therapy regimens and Standard Triple-Drug therapy for eradication of Helicobacter Pylori in patients with Dyspepsia
Public title
Efficacy of sequential therapy in eradication of Helicobacter Pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Dyspepsia for whom endoscopy was performed and those ones that have the positive Helicobacter Pylori infection based on pathology result and those who have not been treated for Helicobacter Pylori eradication before. Exclusion criteria: Patients that need more treatments based on endoscopy results, patients that have severe underling diseases (heart disease, kidney disease, liver disease, etc), pregnant and lactating women, patients who have allergies to drugs we want to use.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 300
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
Ethics committee of Lorstan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad, Lorestan
City
Khorramabad
Postal code
381251698
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
Lums.REC.1394.48

Health conditions studied

1

Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Dyspepsia

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
Eradication of Helicobacter Pylori
Timepoint
6 weeks after the completion of treatment course
Method of measurement
(UBT) Urea Breath Test

Secondary outcomes

1

Description
Side effects of drugs
Timepoint
2 Weeks After Beginning of Treatment
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention 3 (Control group): Standard triple therapy with Omeprazole 20 mg capsule twice a day, Amoxicillin 1 g capsule twice a day and Clarithromycin 500 mg capsule twice a day for 2 weeks
Category
Treatment - Drugs

2

Description
Intervention 1: The sequential regimen is including Omeprazole 20 mg capsule twice a day and Amoxicillin 1 g capsule twice a day for the first week and Omeprazole 20 mg capsule twice a day, Clarithromycin 500 mg capsule twice a day and Metronidazole 500 mg tablet twice a day for the second week
Category
Treatment - Drugs

3

Description
Intervention 2: The sequential regimen is including Omeprazole 20 mg capsule twice a day and Amoxicillin 1 g capsule twice a day for the first week and Omeprazole 20 mg capsule twice a day, Levofloxacin 500 mg capsule twice a day and Metronidazole 500 mg tablet twice a day for the second week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorramabad's Shohadaye Ashayer Hospital
Full name of responsible person
Mosayeb Moradniani, Gastroenterologist, Assistant professor
Street address
Khorramabad's Shohadaye Ashayer Hospital, Enghelab Blvd. Khorramabad, Lorestan
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Lorestan University of Medical Sciences
Full name of responsible person
Morovat Taheri Kalani
Street address
Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad, Lorestan
City
Khorramabad
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, Lorestan 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
Lorstan University of Medical Sciences
Full name of responsible person
Mosayeb Moradniani
Position
Gastroenterologist, Assistant professor
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad, Lorestan
City
Khorramabad
Postal code
6819617691
Phone
+98 66 3341 1439
Fax
Email
dr.m.morad@lums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorstan University of Medical Sciences
Full name of responsible person
Mosayeb Moradniani
Position
Gastroenterologist, Assistant professor
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad, Lorestan
City
Khorramabad
Postal code
6819617691
Phone
+98 66 3341 1439
Fax
Email
dr.m.morad@lums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorstan University of Medical Sciences
Full name of responsible person
Mosayeb Moradniani
Position
Gastroenterologist, Assistant professor
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad, Lorestan
City
Khorramabad
Postal code
6819617691
Phone
+98 66 3341 1439
Fax
Email
dr.m.morad@lums.ac.ir
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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