|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
14 January 2013 |
|
Main ID: |
NCT01219764 |
|
Date of registration:
|
19/05/2010 |
|
Primary sponsor: |
|
|
Public title:
|
A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
|
|
Scientific title:
|
A Randomized Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection |
|
Date of first enrolment:
|
October 2010 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01219764 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Lebanon
| | | | | | | |
|
Contacts
|
|
Name:
|
Ala' I Sharara, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
American University of Beirut Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- documented H.pylori infection by a CLO test or a Urea Breath Test
- sign the informed consent
Exclusion Criteria:
- Age under 18 or older than 80 years
- Allergies to any of the drugs used
- Recent antibiotic therapy (within 2 weeks of enrolment)
- Severe ulcers or bleeding
- Gastric perforation or obstruction
- Previous gastrectomy
- Gastric cancer
- Pregnancy or lactation
- Prior eradication therapy for H. pylori
- Severe concomitant disease or condition making the treatment unlikely to be effective
i.e. alcoholism, drug addiction, and history of poor compliance.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Helicobacter Infections
|
|
Intervention(s)
|
|
Drug: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin
|
|
Primary Outcome(s)
|
|
Number of participants with negative urea breath test post treatment
[Time Frame: 30 days post treatment completion]
|
|
Secondary Outcome(s)
|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: during the 7 days of the treatment]
|
|
Secondary ID(s)
|
|
IM.AS1.25
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|