The aim of this study is to evaluate safety and efficacy of ten days quadruple and triple furazolidone- based regimen in eradication of Helicobacter pylori.
372 H-pylori infected patients with proven peptic ulcer , duodenal and /or gastric erosions by endoscopy will be randomized into three groups: group A(OABF) with furazolidone (F) (200 mg bid);groupB( OABM-F); metronidazole (M) (500 mg bid) for the first5 days, followed by furazolidone (F) (200 mg Bid) for the second 5 days; group C(OAF) with furazolidone (F) (200 mg Tid).Duration of all eradication regimens will be ten days.Two months after treatment, a C14-urea breath test will be performed.Analysis of eradication rates will be done by intention-to-treat and per-protocol methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120715701N1
Registration date:2013-12-31, 1392/10/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-31, 1392/10/10
Registrant information
Name
Marjan Mokhtare
Name of organization / entity
Mazandaran university of medical scienses,Imam Khomeini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
m.mokhtare@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-06-01, 1391/03/12
Expected recruitment end date
2013-01-30, 1391/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Quadruple and Triple Furazolidone Containing Regimens on Eradication of Helicobacter Pylori ,in Patients with Helicobacter pylori Infected Duodenal Ulcer , Gastric Ulcer and/or Erosive Gastrodeudinitis .
Public title
Furazolidone Containing Regimens in Eradication of Helicobacter Pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Helicobacter pylori infected duodenal ulcer; gastric ulcer;Gastric Erosion ;Deudenal Erosion;Age >18 year old.
Exclusion criteria :pregnancy ;lactation ; history of previous H.pylori eradication ; taking antibiotics and/or bismuth and/or non-steroidal anti inflammatory drugs during the previous four weeks; concomitant use of anticoagulant or corticosteroid;consuming substantial amounts of alcohol;,history of gastric surgery; significant underlying disease such as; liver;,renal; pulmonary; cardiac disease and neoplasms ; G6PD deficiency ;history of drug allergy to any medication in this study. .
Age
From 18 years old to 83 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
372
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
Mazandaran University of Medical Sciences and Health Services
2 months after the completion of treatment courser
Method of measurement
Urea Breath Test
Secondary outcomes
1
Description
Adverse effect of Drugs
Timepoint
Daily recording during and after the treatment course
Method of measurement
Medical history and record sheet
Intervention groups
1
Description
Intervention group:triple therapy including ,omperazol 20 mg Bid,amoxycillin 1 gr Bid and furazolidone 200 mg Tid , all of them for 10 days
Category
Treatment - Drugs
2
Description
Intervention group 1:quadrapl therapy including, omperazol 20 mg Bid,amoxycillin 1gr Bid,bismuth 240 mg Bid and furazolidone 200 mg Bid ,all of them for 10 days
Category
Treatment - Drugs
3
Description
Intervention group 2:quadrapl sequential therapy including; omperazol 20 mg Bid,amoxycillin 1 gr Bid and bismuth 240 mg Bid ,all of them for 10 days.Metronidazol 500 mg Bid for first 5 days and then furazolidone 200 mg Bid for second 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr .Marjan Mokhtare
Street address
Razi Street
City
Sari
2
Recruitment center
Name of recruitment center
Tooba Clinic
Full name of responsible person
Dr.Vahid Hoseini ,Gastroenterologist
Street address
City
Sari
3
Recruitment center
Name of recruitment center
Gastroenterologists office or clinic
Full name of responsible person
Dr.Marjan Mokhtare
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mazandaran university of medical scienses
Full name of responsible person
Dr.Ahmadali Enayati
Street address
Moallem Square, Assistance of researches and technology
City
Sari
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, Mazandaran university of medical scienses
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
Mazandaran University of Medical Scienses
Full name of responsible person
Marjan Mokhtare
Position
MD,Gastroenterologist
Other areas of specialty/work
Street address
Imam Khomeini Hospital ,GI Research Center
City
Sari
Postal code
Phone
+98 15122771776
Fax
Email
marjanmokhtare@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center
Full name of responsible person
Marjan Mokhtare
Position
MD,Gastroenterologist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, GI Research Center
City
Sari
Postal code
Phone
+98 15122771776
Fax
Email
marjanmokhtare@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
MD,Gastroenterologist
Other areas of specialty/work
Street address
Joibar3 Way ,Imam Sqr
City
Sari
Postal code
Phone
00
Fax
Email
marjanmokhtare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)