Trial Outcomes & Findings for Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication (NCT NCT02541864)

NCT ID: NCT02541864

Last Updated: 2017-11-24

Results Overview

Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 330 participants
• Primary outcome timeframe: at the 6th week after the end of anti- H. pylori therapy
• Results posted on: 2017-11-24

Participant Flow

Participant milestones

Measure	Pantoprazole+Bismuth+Tetra+Metro pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days	Hybrid Therapy a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days
Overall Study STARTED	164	166
Overall Study COMPLETED	164	166
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication

Baseline characteristics by cohort

Measure	Pantoprazole+Bismuth+Tetra+Metro n=164 Participants pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days	Hybrid Therapy n=166 Participants a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days	Total n=330 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	134 Participants n=5 Participants	136 Participants n=7 Participants	270 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Continuous	53.46 years STANDARD_DEVIATION 12.28 • n=5 Participants	54.48 years STANDARD_DEVIATION 11.45 • n=7 Participants	53.97 years STANDARD_DEVIATION 11.86 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	87 Participants n=7 Participants	157 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	79 Participants n=7 Participants	173 Participants n=5 Participants
Region of Enrollment Taiwan	164 Participants n=5 Participants	166 Participants n=7 Participants	330 Participants n=5 Participants

PRIMARY outcome

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

Population: Intention to treat

Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.

Outcome measures

Measure	Pantoprazole+Bismuth+Tetra+Metro n=164 Participants pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days	Hybrid Therapy n=166 Participants a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days
Number of Participants in Which H. Pylori Was Eradicated	154 participants	154 participants

Adverse Events

Pantoprazole+Bismuth+Tetra+Metro

Serious events: 0 serious events

Other events: 92 other events

Deaths: 0 deaths

Hybrid Therapy

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pantoprazole+Bismuth+Tetra+Metro n=164 participants at risk pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days	Hybrid Therapy n=166 participants at risk a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days
Gastrointestinal disorders Nausea	45.7% 75/164 • Number of events 75 • 2 months	7.2% 12/166 • Number of events 12 • 2 months
Gastrointestinal disorders Dizziness	10.4% 17/164 • Number of events 17 • 2 months	4.2% 7/166 • Number of events 7 • 2 months

Additional Information

Dr. Feng-Woei Tsay

Kaohsiung Veterans General Hospital

Phone: +886-7-3422121

Email: fwchaie@vghks.gov.tw

Results disclosure agreements

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