Trial Outcomes & Findings for Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection (NCT NCT00656968)

NCT ID: NCT00656968

Last Updated: 2015-09-30

Results Overview

Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 232 participants
• Primary outcome timeframe: one month after finishing study drugs
• Results posted on: 2015-09-30

Participant Flow

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.

Participant milestones

Measure	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
Overall Study STARTED	115	117
Overall Study COMPLETED	115	117
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection

Baseline characteristics by cohort

Measure	Concomitant Therapy (A) n=115 Participants esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days	Sequential Therapy (B) n=117 Participants 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	Total n=232 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	98 Participants n=5 Participants	99 Participants n=7 Participants	197 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Age, Continuous	51.8 years STANDARD_DEVIATION 11.3 • n=5 Participants	51.7 years STANDARD_DEVIATION 12 • n=7 Participants	51.74 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	56 Participants n=7 Participants	111 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	61 Participants n=7 Participants	121 Participants n=5 Participants
Region of Enrollment Taiwan	115 participants n=5 Participants	117 participants n=7 Participants	232 participants n=5 Participants

PRIMARY outcome

Timeframe: one month after finishing study drugs

Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Outcome measures

Measure	Concomitant Therapy (A) n=115 Participants esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days	Sequential Therapy (B) n=117 Participants 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
Number of Participants in Which H. Pylori Was Eradicated	92 participants	95 participants

PRIMARY outcome

Timeframe: one month after finishing test therapy

Good drug compliance is defined as taking equal to or more than 80% of eradication medicines

Outcome measures

Measure	Concomitant Therapy (A) n=115 Participants esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days	Sequential Therapy (B) n=117 Participants 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
Number of Participants Who Had Good Drug Compliance	106 participants	104 participants

Adverse Events

Concomitant Therapy (A)

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Sequential Therapy (B)

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Concomitant Therapy (A) n=115 participants at risk esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days	Sequential Therapy (B) n=117 participants at risk 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
Gastrointestinal disorders bad taste	15.7% 18/115 • Number of events 18	10.3% 12/117 • Number of events 12
Nervous system disorders Dizziness	11.3% 13/115 • Number of events 13	8.5% 10/117 • Number of events 10
Nervous system disorders Fatigue	4.3% 5/115 • Number of events 5	11.1% 13/117 • Number of events 13
Nervous system disorders Headache	4.3% 5/115 • Number of events 5	4.3% 5/117 • Number of events 5

Additional Information

Dr. Ping-I Hsu

Kaohsiung Veterans General Hospital

Phone: 886-7-3422121

Email: pihsu@isca.vghks.gov.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place