Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori

This study has been terminated.

(Early termination due to efficacy)

Sponsor:

Information provided by (Responsible Party):

Ming-Cheh Chen, Buddhist Tzu Chi General Hospital

ClinicalTrials.gov Identifier:

NCT01575899

First received: April 10, 2012

Last updated: July 28, 2012

Last verified: July 2012

History of Changes

Results First Received: April 19, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Helicobacter Pylori Infection
Interventions:	Drug: Levofloxacin-Amox/clav. Drug: Clarithromycin-Amoxicillin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We included H. pylori-positive adult patients assessed by the rapid urease test and histology during the period December 2007 to December 2009 from the out-patient clinic of a single medical center located at Hualien, Eastern Taiwan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We excluded patients under the age of 20, woman in pregnancy or breast feeding, those with concomitant illness or conditions (i.e., cardiopulmonary, hepatic, renal diseases, neoplastic diseases), those with severe complication of peptic ulcer disease, like obstruction or perforation, those with allergy to any of the drugs used.

Reporting Groups

	Description
Levofloxacin-Amox/Clav.	7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
Clarithromycin-Amoxicillin	7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
Levofloxacin-Amox/Clav. (Re-eradication)	7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.

Participant Flow: Overall Study

	Levofloxacin-Amox/Clav.	Clarithromycin-Amoxicillin	Levofloxacin-Amox/Clav. (Re-eradication)
STARTED	73	73	62 ^[1]
COMPLETED	68	68	60
NOT COMPLETED	5	5	2
Lost to Follow-up	3	4	2
Protocol Violation	2	1	0

[1]	Included patients still with Hp infection after previous therapy without levofloxacin and Augmentin.

Baseline Characteristics

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Reporting Groups

	Description
Levofloxacin-Amox/Clav.	7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
Clarithromycin-Amoxicillin	7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
Levofloxacin-Amox/Clav. (Re-eradication)	7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
Total	Total of all reporting groups

Baseline Measures

	Levofloxacin-Amox/Clav.	Clarithromycin-Amoxicillin	Levofloxacin-Amox/Clav. (Re-eradication)	Total
Number of Participants [units: participants]	73	73	62	208
Age [units: years] Mean ± Standard Deviation	52.82 ± 12.08	54.63 ± 14.42	54.68 ± 11.81	54.01 ± 12.77
Age, Customized [units: participants]
< 54 years	38	34	25	97
>=54 years	35	39	37	111
Gender [units: participants]
Female	35	40	38	113
Male	38	33	24	95
Resident area ^[1] [units: participants]
Urban area	30	24	19	73
Rural area	43	49	43	135
Endoscopic finding ^[2] [units: participants]
With peptic ulcer	30	35	21	86
Without peptic ulcer	43	38	41	122
Follow up method ^[3] [units: participants]
C13-UBT	65	65	55	185
CLO test	5	4	5	14
No follow up	3	4	2	9

[1]	Comparison about resident area of participants, living in urban area or rural area.
[2]	Comparison between participant's endoscopic finding with or without peptic ulcer disease.
[3]	Information about the follow up method to confirmed the post-treatment Hp status of participants.

Outcome Measures

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1. Primary:

Eradication Rate (Participants Naive to Anti-H. Pylori Treatment) [ Time Frame: 4 weeks after complete use of drug for treatment ]

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2. Secondary:

Eradication Rate of Participants Living in Rural Area. [ Time Frame: 4 weeks after complete use of drug for treatment ]

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3. Other Pre-specified:

Re-eradication Rate [ Time Frame: 4 weeks after complete use of drug for treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The limitation of this study is the local primary resistance of Hp to levofloxacin and to amoxicillin/clavulanate is unknown. We are currently engaged in an on-going investigation of the influence of CYP2C19 genotypes on this new regimen.

Results Point of Contact:

Name/Title: Dr. Ming-Cheh, Chen
Organization: Buddhist Tzu Chi General Hospital
phone: +886-910-521003
e-mail: MingCheh_chen@tzuchi.com.tw

No publications provided

Responsible Party:	Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:	NCT01575899 History of Changes
Other Study ID Numbers:	IRB096-28
Study First Received:	April 10, 2012
Results First Received:	April 19, 2012
Last Updated:	July 28, 2012
Health Authority:	Taiwan: Institutional Review Board

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