UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015375 |
|---|---|
| Receipt number | R000017894 |
| Scientific Title | Comparison of efficacy and safety of levofloxacin-containing versus standard sequential therapy in eradication of Helicobacter pylori infection in Korea |
| Date of disclosure of the study information | 2014/10/08 |
| Last modified on | 2014/10/08 20:27:27 |
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Basic information
Public title
Comparison of efficacy and safety of levofloxacin-containing versus standard sequential therapy in eradication of Helicobacter pylori infection in Korea
Acronym
Levofloxacin-containing sequential therapy in Korea
Scientific Title
Comparison of efficacy and safety of levofloxacin-containing versus standard sequential therapy in eradication of Helicobacter pylori infection in Korea
Scientific Title:Acronym
Levofloxacin-containing sequential therapy in Korea
Region
| Asia(except Japan) |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Levofloxacin-containing versus standard sequential therapy in eradication of Helicobacter pylori infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate of H pylori infection
Key secondary outcomes
Drug adherence and the frequency of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One group was treated with standard sequential therapy (SST) (ie, rabeprazole 20 mg twice daily + amoxicillin 1 g twice daily for 5 days, followed by rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + metronidazole 500 mg twice daily for five more days).
Interventions/Control_2
The second group was treated with levofloxacin-containing sequential therapy (LST) (ie, rabeprazole 20 mg twice daily + amoxicillin 1g twice daily for 5 days followed by rabeprazole 20 mg twice daily + levofloxacin 250 mg twice daily + metronidazole 500 mg twice daily for five more days).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
dyspeptic patients aged 18-76 years with H. pylori infection
Key exclusion criteria
(1) patients with previous H. pylori eradication therapy; (2) patients treated with H2 receptor antagonist, PPI, and antibiotics in the previous 4 weeks, or nonsteroidal anti-inflammatory drug (NSAID) in the previous 2 weeks; (3) pregnant or lactating women; (4) patients who suffered from serious diseases such as severe liver disease, renal disease, and cerebrovascular disease; (5) patients who had a drug allergy to the study drugs; and (6) patients with previous gastric surgery.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hyuk Lee |
Organization
Yonsei University
Division name
Dpt. of Medicine
Zip code
Address
Shinchon-dong, Seoul, Korea
TEL
82-2-2228-1978
leehyuk@skku.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hyuk Lee |
Organization
Yonsei University
Division name
Dpt. of Medicine
Zip code
Address
Shinchon-dong, Seoul, Korea
TEL
82-2-2228-1978
Homepage URL
leehyuk@skku.edu
Sponsor or person
Institute
Severance Hospital, Yonsei University
Institute
Department
Personal name
Funding Source
Organization
Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology (NRF-2012R1A1A1005646)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 08 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 08 | Day |
Last modified on
| 2014 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017894
