The goal of this study is to determine the effect of different creatinine clearance levels on helicobacter pylori(HP) eradication rate in peptic ulcer patients.
Not blinded, No placebo-controlled, single center study.
Inclusion criteria: Peptic ulcer patients, which have recently been proven by endoscopy and are HP positive, are enrolled.
Exclusion criteria: Pregnant women ; patients with cancer ; liver failure; smoking , alcohol consumption ; drug allergy; use of proton pomp inhibitors (PPIs), non steroid anti inflammatory drugs (NSAIDS), bismuth and antibiotics in last 4 weeks.
Target sample size is 125 patients.
Peptic ulcer patients which are HP positive are divided into five groups according to creatinine clearance. All of them are given standard triple therapy and in creatinine clearance less than 30 milliliter (ml) per minute (ml/min) Clarithromycin and amoxicillin dose is reduced by 50 percent. HP eradication rate is evaluated in the different groups with urease breath test (UBT) 6 weeks after therapy ends. Intervention time is winter 1391 and spring and summer 1392.
Study outcome is HP eradication rates in different groups according to creatinine clearance.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060913609N1
Registration date:2013-08-18, 1392/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Mehdi Alimadadi
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1660
Email address
grcgh@res.gehd.org
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of different creatinine clearance levels on helicobacter pylori eradication rate in peptic ulcer patients.
Public title
The amount of helicobacter pylori eradication in renal failure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Peptic ulcer patients, which have recently been proven by endoscopy and are HP positive, are enrolled.
Exclusion criteria: Pregnant women ; patients with cancer ; liver failure; smoking , alcohol consumption ; drug allergy; use of proton pomp inhibitors (PPIs), non steroid anti inflammatory drugs (NSAIDS), bismuth and antibiotics in last 4 weeks.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
125
Randomization (investigator's opinion)
N/A
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 Golestan University of Medical Sciences
Street address
High education department of Falsafi, The Shast Kola road, Sari to Gorgan road 5 Kilometer, Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2013-03-17, 1391/12/27
Ethics committee reference number
356191122715
Health conditions studied
1
Description of health condition studied
peptic ulcer
ICD-10 code
K27
ICD-10 code description
gastroduodenal ulcer NOS peptic ulcer NOS
Primary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
Before and 8 weeks after intervention
Method of measurement
Before intervention in antrum sample with rapid urease test and 8 weeks after intervention with urease breath test
Secondary outcomes
1
Description
Creatinine clearance
Timepoint
3 months before the intervention and at the begining and during the intervention.
Method of measurement
According to formula 24 hour urine volume× (urine creatinine/serum creatinine)
Intervention groups
1
Description
Group 1: Capsule omeprazol 20 milligram (mg) twice daily (OSVEH Pharmaceutical Company); Tablet clarithromycin 500 mg twice daily (CHEMIDAROU Pharmaceutical Company); Capsule amoxicillin 1 gram (gr) twice daily (FARABI Pharmaceutical Company) all of them for 2 weeks.
Category
Treatment - Drugs
2
Description
Group 2: Capsule omeprazol 20 milligram (mg) twice daily (OSVEH Pharmaceutical Company); Tablet clarithromycin 500 mg twice daily (CHEMIDAROU Pharmaceutical Company); Capsule amoxicillin 1 gram (gr) twice daily (FARABI Pharmaceutical Company) all of them for 2 weeks.
Category
Treatment - Drugs
3
Description
Group 3: Capsule omeprazol 20 milligram (mg) twice daily (OSVEH Pharmaceutical Company); Tablet clarithromycin 500 mg twice daily (CHEMIDAROU Pharmaceutical Company); Capsule amoxicillin 1 gram (gr) twice daily (FARABI Pharmaceutical Company) all of them for 2 weeks.
Category
Treatment - Drugs
4
Description
Group 4: Capsule omeprazol 20 milligram (mg) twice daily (OSVEH Pharmaceutical Company); Tablet clarithromycin 250 mg twice daily (CHEMIDAROU Pharmaceutical Company); Capsule amoxicillin 500 mg twice daily (FARABI Pharmaceutical Company) all of them for 2 weeks.
Category
Treatment - Drugs
5
Description
Group 5: Capsule omeprazol 20 milligram (mg) twice daily (OSVEH Pharmaceutical Company); Tablet clarithromycin 250 mg twice daily (CHEMIDAROU Pharmaceutical Company); Capsule amoxicillin 500 mg twice daily (FARABI Pharmaceutical Company) all of them for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar Hospital
Full name of responsible person
Mohammad Reza Seyyed Majidi, Gastroenterologist, Assistant professor
Street address
5 Azar Street, Gorgan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Golestan University of Medical Sciences
Full name of responsible person
Kamran Haidari, Research Assistant
Street address
High education department of Falsafi, The Shast Kola road, Sari to Gorgan road 5 Kilometer, Gorgan
City
Gorgan
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, Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Mehdi Alimadadi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
High education department of Falsafi, The Shast Kola road, Sari to Gorgan road 5 Kilometer, Gorgan
City
Gorgan
Postal code
4934174515
Phone
+98 17 1442 1653
Fax
+98 17 1444 0225
Email
alimadadi1360@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mohammad Reza Seyyed Majidi
Position
Gastroenterologist, Assistant professor
Other areas of specialty/work
Street address
High education department of Falsafi, The Shast Kola road, Sari to Gorgan road 5 Kilometer, Gorgan
City
Gorgan
Postal code
4934174515
Phone
+98 17 1442 1653
Fax
+98 17 1444 0225
Email
mrsmajidi55@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mehdi Alimadadi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
High education department of Falsafi, The Shast Kola road, Sari to Gorgan road 5 Kilometer, Gorgan
City
Gorgan
Postal code
4934174515
Phone
+98 17 1442 1653
Fax
+98 17 1444 0225
Email
alimadadi1360@yahoo.com
Web page address
www.goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)