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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name