The primary aim of this study is to compare eradication rate and the acceptability of a new sequential treatment regimen. We designed an open-label, randomized, parallel-arm study and 130 patients with persistent dyspepsia, who refereed for upper endoscopy and their rapid urease test is positive, are recruited for helicobacter pylori eradication. Patients with history of HP eradication or on PPI or recent antibiotic therapy are excluded. Patients are randomized into two groups: sequential and classic triple therapy. Triple therapy group are prescribed omeperazol 20mg BID and amoxcycilin 1000mg /12h and chlarythrimicin 500mg/12h for 10 days. Sequential treatment group are prescribed amoxcycilin 1000mg/12h and omeprazol 20mg/bid for first 5 days and chlarythromicin 500mg/12h and omeprazol 20mg/BID and metronidazol 500mg/12h for next 5 days. Both groups will have PPI BD for next 20 days. After 5, 10, 30 days they are contacted and asked about symptoms and side effects of medication. Information will gather based on our check list and questionnaire. All patients who are tolerated more than 80% of treatment are included for evaluation and analysis. Four to five weeks after end of antibiotics treatment they will be send for UBT and results of HP eradication and side effects will analyse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810152988N1
Registration date:2010-03-14, 1388/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-14, 1388/12/23
Registrant information
Name
Azita Ganji
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 2327
Email address
ganjia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical siences
Expected recruitment start date
2010-03-14, 1388/12/23
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing sequential treatment with classic triple therapy for helicobacter pylori eradication
Public title
Sequential therapy in Helicobacter pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with positive rapid urease test (RUT) who had indication of helicobacter eradication. Exclusion criteria: history of HP eradication, patients on PPI, history of allergic reaction to our medicine, history of any antibiotic in last 4 weeks, renal failure.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
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 Mashhad university of medical sciences
Street address
Danshgeh street
City
Mashhad
Postal code
Approval date
empty
Ethics committee reference number
88203
Health conditions studied
1
Description of health condition studied
Eradication of Helicobacter pylori
ICD-10 code
K27
ICD-10 code description
Peptic ulcer, site unspecified
2
Description of health condition studied
Eradication of Helicobacter pylori
ICD-10 code
K29
ICD-10 code description
Gastritis and duodenitis
Primary outcomes
1
Description
helicobacter pylori eradication
Timepoint
45th day
Method of measurement
Urease btreath test
Secondary outcomes
1
Description
side effects of treatment
Timepoint
day 5, 10, 30
Method of measurement
contact by phone and if needed visit in the clinic
Intervention groups
1
Description
Sequential treatment: omeprazole 20mg twice daily/Amoxicillin 1gr every 12 hours for first 5 day and in next 5 days, Omeprazole 20 mg /Clarithromycin 500 mg and Metronidazole 500 mg every 12 hours and for last 20 days just omeprazole 20 mg twice daily.
Category
Treatment - Drugs
2
Description
Classic treatment (triple therapy): omeprazole 20mg, amoxicillin 1 g, clarithromycin 500mg every 12 hours for 10 days and for last 20 days just omeprazole 20 mg twice daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
DR Jalil Tavakol afshari
Street address
Mashhad university of Medical siences, Ghoryshi building
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Siences
Full name of responsible person
Azita Ganji
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1882 2327
Fax
Email
ganjia@mums.ac.ir , azita_ganji@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashad University of medical siences
Full name of responsible person
Azita Ganji
Position
Assistant professor, Gastroentrologist
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1882 2327
Fax
Email
ganjia@mums.ac.ir , azita_ganji@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad university of medical siences
Full name of responsible person
Azita Ganji
Position
Gastroenterologist
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Mashhad
Postal code
Phone
+98 88 22327
Fax
+98 88 22327
Email
ganjia@mums.ac.ir , aita_ganji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)