Trial Outcomes & Findings for Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy (NCT NCT02646332)

Last Updated: 2020-11-24

Results Overview

To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Recruitment status

COMPLETED

Study phase

Target enrollment

248 participants

Primary outcome timeframe

sixth week after the end of anti- H. pylori therapy

Results posted on

2020-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox) a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily (dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily	Dexlan+Clarith+Amox+Metro dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days
Overall Study STARTED	124	124
Overall Study COMPLETED	124	121
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox) a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily (dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily	Dexlan+Clarith+Amox+Metro dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox) n=124 Participants a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily (dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily	Dexlan+Clarith+Amox+Metro n=124 Participants dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days	Total n=248 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 12.3 • n=5 Participants	54.7 years STANDARD_DEVIATION 11.2 • n=7 Participants	55.5 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	64 Participants n=7 Participants	130 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	60 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	124 Participants n=5 Participants	124 Participants n=7 Participants	248 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Taiwan	124 participants n=5 Participants	124 participants n=7 Participants	248 participants n=5 Participants
History of smoking	18 participants n=5 Participants	26 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: sixth week after the end of anti- H. pylori therapy

Population: Intention to treat

To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Outcome measures

Outcome measures
Measure	(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox) n=124 Participants a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily (dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily	Dexlan+Clarith+Amox+Metro n=124 Participants dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days
Number of Participants in Which H. Pylori Was Eradicated	124 participants	121 participants

Adverse Events

(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Dexlan+Clarith+Amox+Metro

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox) n=124 participants at risk a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily (dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily	Dexlan+Clarith+Amox+Metro n=124 participants at risk dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days
Gastrointestinal disorders Nausea	8.9% 11/124 • Number of events 11 • 2 months	10.5% 13/124 • Number of events 13 • 2 months
Gastrointestinal disorders Abdominal pain	4.0% 5/124 • Number of events 5 • 2 months	18.5% 23/124 • Number of events 23 • 2 months
Gastrointestinal disorders Diarrhea	4.8% 6/124 • Number of events 6 • 2 months	4.8% 6/124 • Number of events 6 • 2 months
Skin and subcutaneous tissue disorders Skin rash	2.4% 3/124 • Number of events 3 • 2 months	4.8% 6/124 • Number of events 6 • 2 months

Additional Information

Dr. Ping-I Hsu

Kaohsiung Veterans General Hospital

Phone: +886-7-3422121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place