Trial Outcomes & Findings for High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population (NCT NCT05342532)
NCT ID: NCT05342532
Last Updated: 2023-02-01
Results Overview
The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
112 participants
Primary outcome timeframe
end of study at 6 weeks
Results posted on
2023-02-01
Participant Flow
Participant milestones
| Measure |
High Dose Dual Therapy
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
|
Standard Triple Therapy
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Clarithromycin: 500 mg twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
54
|
|
Overall Study
COMPLETED
|
43
|
19
|
|
Overall Study
NOT COMPLETED
|
15
|
35
|
Reasons for withdrawal
| Measure |
High Dose Dual Therapy
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
|
Standard Triple Therapy
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Clarithromycin: 500 mg twice daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
20
|
|
Overall Study
Lost to Follow-up
|
10
|
15
|
Baseline Characteristics
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Baseline characteristics by cohort
| Measure |
High Dose Dual Therapy
n=58 Participants
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
|
Standard Triple Therapy
n=54 Participants
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Clarithromycin: 500 mg twice daily
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 15 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
51 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: end of study at 6 weeksThe number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.
Outcome measures
| Measure |
High Dose Dual Therapy
n=58 Participants
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
|
Standard Triple Therapy
n=54 Participants
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Clarithromycin: 500 mg twice daily
|
|---|---|---|
|
Number of Participant With Eradication of Disease
|
37 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: end of study at 6 weeksPatient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia
Outcome measures
| Measure |
High Dose Dual Therapy
n=58 Participants
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
|
Standard Triple Therapy
n=54 Participants
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Clarithromycin: 500 mg twice daily
|
|---|---|---|
|
Number of Participants With Protocol Specific Adverse Events
|
5 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: end of study at 6 weeksPatients were provided a medication log to self-report drug compliance. After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. At the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications).
Outcome measures
| Measure |
High Dose Dual Therapy
n=58 Participants
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
|
Standard Triple Therapy
n=54 Participants
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Clarithromycin: 500 mg twice daily
|
|---|---|---|
|
Number of Participants Completing at Least 90% of All Prescribed Medications
|
58 Participants
|
54 Participants
|
Adverse Events
High Dose Dual Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard Triple Therapy
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose Dual Therapy
n=58 participants at risk
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
|
Standard Triple Therapy
n=54 participants at risk
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Clarithromycin: 500 mg twice daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
3/58 • 6 weeks
|
13.0%
7/54 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/58 • 6 weeks
|
3.7%
2/54 • 6 weeks
|
|
Gastrointestinal disorders
Dysguesia
|
0.00%
0/58 • 6 weeks
|
7.4%
4/54 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/58 • 6 weeks
|
3.7%
2/54 • 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • 6 weeks
|
9.3%
5/54 • 6 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/58 • 6 weeks
|
0.00%
0/54 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place