Trial Outcomes & Findings for Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection (NCT NCT03124199)

NCT ID: NCT03124199

Last Updated: 2018-03-22

Results Overview

Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 40 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2018-03-22

Participant Flow

Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment

There were no significant events in the study after patient enrollment and before assignment

Participant milestones

Measure	Rifaximin Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy
Overall Study STARTED	40
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Rifaximin Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy
Overall Study Lost to Follow-up	4

Baseline Characteristics

Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection

Baseline characteristics by cohort

Measure	Rifaximin n=40 Participants Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment Spain	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment

Outcome measures

Measure	Rifaximin n=40 Participants Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy
Percentage of Participants With H.Pylori Infection Eradication	61 percentage of participants Interval 45.0 to 77.0

SECONDARY outcome

Timeframe: 1 month

Patients with side effects present during treatment and in the 4 weeks after end of treatment

Outcome measures

Measure	Rifaximin n=36 Participants Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy
Tolerability of Treatment with diarrhea	13 participants
Tolerability of Treatment with metallic taste	9 participants
Tolerability of Treatment headache	5 participants
Tolerability of Treatment nausea	5 participants
Tolerability of Treatment abdominal pain	1 participants

SECONDARY outcome

Timeframe: 1 month

Percentage of patients that has comply with treatment, considered as intake of more than 90% of study drugs in patients who attended the post-treatment visit.

Outcome measures

Measure	Rifaximin n=36 Participants Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy
Compliance With Treatment of Patients That Completed the Study	100 percentage of participants

Adverse Events

Rifaximin

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rifaximin n=36 participants at risk；n=40 participants at risk Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy
Gastrointestinal disorders Diarrhea	36.1% 13/36 • 1 month and 10 days
Gastrointestinal disorders Metallic Taste	25.0% 9/36 • 1 month and 10 days
General disorders Headache	13.9% 5/36 • 1 month and 10 days
Gastrointestinal disorders Nausea	13.9% 5/36 • 1 month and 10 days
Gastrointestinal disorders abdominal pain	2.8% 1/36 • 1 month and 10 days

Additional Information

Mercedes Ramas

Hospital Universitario de la Princesa

Phone: 913093911

Email: mercedesramas@gmail.com

Results disclosure agreements

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