Goal: The effect of Clidinium-Chlordiazepoxide (Clidinium- C) on helicobacter pylori (HP) eradication in patients with peptic ulcer. A randomized, not blinded, no placebo controlled, single center, trial phase 2 study.
Inclusion criteria: Patients with peptic ulcer in endoscopy and positive rapid urease test for HP infection are enrolled.
Exclusion criteria: Patients that are taking non steroid anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), bismuth preparations or antibiotics during the last four weeks and with prior HP eradication, glaucoma, prostatic hypertrophy, pregnancy , lactation and intolerable side effects of clidinium-c are excluded.
Target sample size is 66 patients. HP positive patients receive standard triple therapy of omeprazol 40 milligram (mg), clarithromycin 1 gram (gr) and amoxicillin 2 gr for 2 weeks. Clidinium-c is added for intervention group one tablet before each meal. 6 weeks after therapy ends urease breath test (UBT) is done. Intervention time is spring and summer 1392. In this study the effect of clidinium-c on HP eradication is studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041112977N1
Registration date:2013-07-29, 1392/05/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-29, 1392/05/07
Registrant information
Name
Saba Homapour
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1653
Email address
grcgh@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of clidinium c with triple therapy in comparison with standard triple therapy for helicobacter pylori eradication in peptic ulcer patients
Public title
The effect of Clidinium c on peptic ulcer treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with peptic ulcer in endoscopy and positive rapid urease test for helicobacter pylori (HP) infection are enrolled.
Exclusion criteria: Patients that are taking non steroid anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), bismuth preparations or antibiotics during the last four weeks and with prior HP eradication, glaucoma, prostatic hypertrophy, pregnancy , lactation and intolerable side effects of clidinium-c are excluded.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study randomization is done with table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Gorgan, High education department of Falsafi, The Shast kola road, Sari to Gorgan road 5 Kilometer
City
Gorgan
Postal code
4934174515
Approval date
2013-03-17, 1391/12/27
Ethics committee reference number
356191122713
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 breathe test
Secondary outcomes
1
Description
Age
Timepoint
Before intervention
Method of measurement
Year-Birth certificate
2
Description
Sex
Timepoint
Before intervention
Method of measurement
Female/male-Observation
Intervention groups
1
Description
Intervention 1 : Capsule Omeprazol 40 miligram(mg) (Osveh Pharmaceutical Company) , Tablet (tab)clarithromycine 1 gram(gr) (Chemidarou Pharmaceutical Company) and capsule amoxicilline 2 gr (Kosar Pharmaceutical Company) all daily plus tab clidinium c (Clidinium Bromide 2.5 mg + Chlorodiazepoxide HCL 5 mg)(Sobhan Pharmaceutical Company) one tablet before each meal all of them for 2 weeks.
Category
Treatment - Drugs
2
Description
Intervention 2 : Capsule Omeprazol 40 miligram(mg) (Osveh Pharmaceutical Company) , Tablet (tab)clarithromycine 1 gram(gr) (Chemidarou Pharmaceutical Company) and capsule amoxicilline 2 gr (Kosar Pharmaceutical Company) all daily for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan 5 Azar Hospital
Full name of responsible person
Mohammad Reza Seyyed Majidi Gastroenterologist/ assistant professor
Street address
Gorgan, 5Azar Street
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
Gorgan, High education department of Falsafi, The Shast kola road, Sari to Gorgan road 5 Kilometer
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
Saba Homapour
Position
Intern
Other areas of specialty/work
Street address
Gorgan, High education department of Falsafi, The Shast kola road, Sari to Gorgan road 5 Kilometer
City
Gorgan
Postal code
4934174515
Phone
+98 17 1442 1653
Fax
+98 17 1444 0225
Email
homapoorsaba@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
Gorgan, High education department of Falsafi, The Shast kola road, Sari to Gorgan road 5 Kilometer
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
Saba Homapour
Position
Intern
Other areas of specialty/work
Street address
Gorgan, High education department of Falsafi, The Shast kola road, Sari to Gorgan road 5 Kilometer
City
Gorgan
Postal code
4934174515
Phone
+98 17 1442 1653
Fax
+98 17 1444 0225
Email
homapoorsaba@yahoo.com
Web page address
www.goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)