Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection - Study Results

Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection (960025)

This study has been completed.

Study NCT00656968 Information provided by Kaohsiung Veterans General Hospital.

First Received on January 3, 2008. Last Updated on July 5, 2011 History of Changes

Results First Received: August 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Helicobacter Infection
Interventions:	Drug: 10-day sequential treatment Drug: 10-day concomitant therapy

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We surveyed patients who visited the gastroenterological clinic of Kaohsiung Medical University Hospital (KMUH), Kaohsiung Veteran General Hospital (KVGH). A total of 232 H. pylori-infected patients were randomly assigned to sequential (n = 117) or concomitant (n = 115) therapies.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Concomitant Therapy (A)	esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
Sequential Therapy (B)	esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Concomitant Therapy (A)	esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
Sequential Therapy (B)	esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10

Baseline Measures

	Concomitant Therapy (A)	Sequential Therapy (B)	Total
Number of Participants [units: participants]	115	117	232
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	98	99	197
>=65 years	17	18	35
Age [units: years] Mean ± Standard Deviation	51.8 ± 11.3	51.7 ± 12	51.74 ± 11.6
Gender [units: participants]
Female	55	56	111
Male	60	61	121
Region of Enrollment [units: participants]
Taiwan	115	117	232

Outcome Measures

1. Primary:

Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: one month after finishing study drugs ]

Show Outcome Measure 1

2. Primary:

Number of Participants Who Had Good Drug Compliance [ Time Frame: one month after finishing test therapy ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

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 trial was performed in a single country

Results Point of Contact:

Name/Title: Dr. Ping-I Hsu
Organization: Kaohsiung Veterans General Hospital
phone: 886-7-3422121 ext 8233
e-mail: pihsu@isca.vghks.gov.tw

Publications:

Responsible Party:	DENG CHYANG WU, MD/PHD, Kaohsiung Medical University Hospital
ClinicalTrials.gov Identifier:	NCT00656968 History of Changes
Other Study ID Numbers:	KMU-IRB00003151, VGHKS95-CT3-11
Study First Received:	January 3, 2008
Results First Received:	August 17, 2010
Last Updated:	July 5, 2011
Health Authority:	Taiwan: Institutional Review Board