Trial Outcomes & Findings for Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection (NCT NCT02359435)

NCT ID: NCT02359435

Last Updated: 2017-04-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 440 participants
• Primary outcome timeframe: at the 6th week after the end of anti- H. pylori therapy
• Results posted on: 2017-04-18

Participant Flow

1. recruitment period: Oct 2012 - Mar 2015 2. Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital

None were excluded following participant enrollment.

Participant milestones

Measure	Reverse Hybrid Therapy pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days	Standard Triple Therapy pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
Overall Study STARTED	220	220
Overall Study COMPLETED	216	216
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Reverse Hybrid Therapy pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days	Standard Triple Therapy pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
Overall Study Lost to Follow-up	4	4

Baseline Characteristics

Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection

Baseline characteristics by cohort

Measure	Reverse Hybrid Therapy n=220 Participants pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days	Standard Triple Therapy n=220 Participants pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days	Total n=440 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	154 Participants n=5 Participants	153 Participants n=7 Participants	307 Participants n=5 Participants
Age, Categorical >=65 years	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Age, Continuous	52.6 years STANDARD_DEVIATION 12.9 • n=5 Participants	53.4 years STANDARD_DEVIATION 12.2 • n=7 Participants	52.83 years STANDARD_DEVIATION 12.58 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	101 Participants n=7 Participants	207 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	119 Participants n=7 Participants	233 Participants n=5 Participants
Region of Enrollment Taiwan	220 participants n=5 Participants	220 participants n=7 Participants	440 participants n=5 Participants

PRIMARY outcome

Timeframe: at the 6th week after the end of anti- H. pylori therapy

Population: Intention to treat

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

Outcome measures

Measure	Reverse Hybrid Therapy n=220 Participants pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days	Standard Triple Therapy n=220 Participants pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
Number of Participants in Which H. Pylori Was Eradicated	206 participants	191 participants

Adverse Events

Reverse Hybrid Therapy

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Standard Triple Therapy

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Reverse Hybrid Therapy n=220 participants at risk pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days	Standard Triple Therapy n=220 participants at risk pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
Gastrointestinal disorders Nausea	6.8% 15/220 • Number of events 15 • 2 months	2.7% 6/220 • Number of events 6 • 2 months
Nervous system disorders Dizziness	3.2% 7/220 • Number of events 7 • 2 months	4.1% 9/220 • Number of events 9 • 2 months

Additional Information

Dr. Ping-I Hsu

Kaohsiung Veterans General Hospital

Phone: +886-7-3422121

Email: pihsu@vghks.gov.tw

Results disclosure agreements

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